Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-04 @ 2:28 PM
Study NCT ID:
NCT00595959
Status:
COMPLETED
Last Update Posted:
2011-07-12
First Post:
2008-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.rasmussen@spnc.com', 'phone': '719-447-2471', 'title': 'Thomas M. Rasmussen V.P. Clinical Affairs', 'organization': 'Spectranetics Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Non-randomized study'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System', 'otherNumAtRisk': 65, 'otherNumAffected': 8, 'seriousNumAtRisk': 65, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Hematoma at access site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Occlusion to treated leg other than at lesion site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Worsening coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right renal artery and non-treated leg stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery bypass graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck, back and shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sternum infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Laser Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'spread': '17.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'pValueComment': 'No adjustments', 'groupDescription': 'Comparing to an expected value of 20% reduction from initial to post-laser', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at time of procedure', 'description': 'The primary efficacy endpoint is laser success, defined as achieving \\>/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment.', 'unitOfMeasure': 'percent reduction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'PRIMARY', 'title': 'Major Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From discharge through the 6 month follow-up', 'description': 'The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'classes': [{'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'measured at time of procedure', 'description': 'Acute procedural success, defined as achievement of \\</= 30% final residual stenosis, as visually assessed by angiography after all adjunctive treatment(s) deemed necessary by the treating physician. Measures % of patients who achieved a final residual stenosis of \\</=30%.', 'unitOfMeasure': 'percent with </=30% RS', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol. All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Minimum and Maximum Lumen Diameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'classes': [{'title': 'Post pilot channel max lumen diameter', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Post Turbo-Booster max lumen diameter', 'categories': [{'measurements': [{'value': '5.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Post pilot channel min lumen diameter', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Post Turbo-Booster min lumen diameter', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measured at time of procedure', 'description': 'Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS).', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol'}, {'type': 'SECONDARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'classes': [{'title': '30 days; n=65', 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}]}]}, {'title': '6 months; n=59', 'categories': [{'measurements': [{'value': '59.3', 'groupId': 'OG000'}]}]}, {'title': '12 months; n=46', 'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'measured post discharge thorugh 12 Months follow-up', 'description': 'Clinical success, defined as primary patency (≤ 50% stenosis at the treatment site), as assessed by duplex Doppler ultrasound at 30 days, six (6) months and 12 months post-procedure', 'unitOfMeasure': 'percent of patients', 'reportingStatus': 'POSTED', 'populationDescription': '65 patients at 30 days; 59 at 6 months; 46 at 12 months'}, {'type': 'SECONDARY', 'title': 'Assisted Primary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'classes': [{'title': '30 days; n=65', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': '6 months; n=64', 'categories': [{'measurements': [{'value': '85.9', 'groupId': 'OG000'}]}]}, {'title': '12 months; n=63', 'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 12 Months', 'description': 'Incidence of freedom from assisted primary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a stenosis (patent vessel) at the treatment site to prevent reocclusion', 'unitOfMeasure': '% pts free from assisted primary patency', 'reportingStatus': 'POSTED', 'populationDescription': '65 at 30 days; 64 at 6 months; 63 at 12 months'}, {'type': 'SECONDARY', 'title': 'Assisted Secondary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'classes': [{'title': '30 days; n=65', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': '6 months; n=64', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': '12 months; n=63', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 12 Month', 'description': 'Incidence of freedom from assisted secondary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site', 'unitOfMeasure': '% pts free from secondary patency', 'reportingStatus': 'POSTED', 'populationDescription': '65 at 30 days; 64 at 6 months; 63 at 12 months'}, {'type': 'SECONDARY', 'title': 'Patients With >50% Stenosis Measured by Duplex Ultrasound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'classes': [{'title': '30 days; n=65', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}, {'title': '6 months; n=59', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000'}]}]}, {'title': '12 months; n=46', 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 12 Month', 'description': 'Percentage of patients with \\>50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure).', 'unitOfMeasure': 'percent of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol; 65 patients at 30 days; 59 at 6 months and 46 at 12 months'}, {'type': 'POST_HOC', 'title': 'Walking Impairment Questionare (WIQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'classes': [{'title': 'baseline; n=65', 'categories': [{'measurements': [{'value': '45.6', 'spread': '21.3', 'groupId': 'OG000'}]}]}, {'title': '30 days; n=65', 'categories': [{'measurements': [{'value': '69.9', 'spread': '23.7', 'groupId': 'OG000'}]}]}, {'title': '6 months; n=64', 'categories': [{'measurements': [{'value': '64.7', 'spread': '27.1', 'groupId': 'OG000'}]}]}, {'title': '12 months; n=63', 'categories': [{'measurements': [{'value': '65.1', 'spread': '25.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measured at each follow-up period', 'description': 'Measures difficulty in walking before and after treatment. Defined by comparing the responses to a WIQ at pre-treatment with the responses at 30 days, six (6) months and 12 months post-procedure. Higher score is better (scale 0-100).', 'unitOfMeasure': 'units on a scale 0-100', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '65 patients at baseline and 30 days; 64 at 6 mo; 63 at 12 mo'}, {'type': 'SECONDARY', 'title': 'Rutherford Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'classes': [{'title': 'baseline; n=63', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': '30 days; n=62', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': '6 months; n=62', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': '12 months; n=63', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through 12 Months', 'description': 'Rutherford Classification at 30 days, six (6) and 12 months post-procedure. Physician assessed based on ankle pressures and treadmill testing. Rutherford scale: 0=best, 6=worst', 'unitOfMeasure': 'units on a scale of 0-6', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '63 at baseline; 62 at 30days and 6 months; 63 at 12 months'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'classes': [{'title': 'Procedure/24 hours', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '30 days', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 12 Months', 'description': 'Adverse events during procedure and prior to release from the hospital, at 30 days, six (6) months, and 12 months post-procedure.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Volumetric Plaque Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'classes': [{'title': 'Post pilot channel plaque volume', 'categories': [{'measurements': [{'value': '200.8', 'spread': '61.0', 'groupId': 'OG000'}]}]}, {'title': 'Post Turbo Booster plaque volume', 'categories': [{'measurements': [{'value': '192.8', 'spread': '61.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measured at time of procedure', 'description': 'Volumetric plaque reduction immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by IVUS. Actual volume of plaque present is presented for each measurement point.', 'unitOfMeasure': 'millimeters cubed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients were recruited from investigator patient referral base. Recruitment occurred between November 2006 and March 2007', 'preAssignmentDetails': 'Patients were screened for inclusion/exclusion criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.3', 'spread': '10.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-13', 'studyFirstSubmitDate': '2008-01-04', 'resultsFirstSubmitDate': '2009-02-23', 'studyFirstSubmitQcDate': '2008-01-04', 'lastUpdatePostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-30', 'studyFirstPostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Laser Success', 'timeFrame': 'Measured at time of procedure', 'description': 'The primary efficacy endpoint is laser success, defined as achieving \\>/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment.'}, {'measure': 'Major Adverse Events', 'timeFrame': 'From discharge through the 6 month follow-up', 'description': 'The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death.'}], 'secondaryOutcomes': [{'measure': 'Procedural Success', 'timeFrame': 'measured at time of procedure', 'description': 'Acute procedural success, defined as achievement of \\</= 30% final residual stenosis, as visually assessed by angiography after all adjunctive treatment(s) deemed necessary by the treating physician. Measures % of patients who achieved a final residual stenosis of \\</=30%.'}, {'measure': 'Minimum and Maximum Lumen Diameters', 'timeFrame': 'measured at time of procedure', 'description': 'Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS).'}, {'measure': 'Clinical Success', 'timeFrame': 'measured post discharge thorugh 12 Months follow-up', 'description': 'Clinical success, defined as primary patency (≤ 50% stenosis at the treatment site), as assessed by duplex Doppler ultrasound at 30 days, six (6) months and 12 months post-procedure'}, {'measure': 'Assisted Primary Patency', 'timeFrame': 'Through 12 Months', 'description': 'Incidence of freedom from assisted primary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a stenosis (patent vessel) at the treatment site to prevent reocclusion'}, {'measure': 'Assisted Secondary Patency', 'timeFrame': 'Through 12 Month', 'description': 'Incidence of freedom from assisted secondary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site'}, {'measure': 'Patients With >50% Stenosis Measured by Duplex Ultrasound', 'timeFrame': 'Through 12 Month', 'description': 'Percentage of patients with \\>50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure).'}, {'measure': 'Rutherford Classification', 'timeFrame': 'Through 12 Months', 'description': 'Rutherford Classification at 30 days, six (6) and 12 months post-procedure. Physician assessed based on ankle pressures and treadmill testing. Rutherford scale: 0=best, 6=worst'}, {'measure': 'Adverse Events', 'timeFrame': 'Through 12 Months', 'description': 'Adverse events during procedure and prior to release from the hospital, at 30 days, six (6) months, and 12 months post-procedure.'}, {'measure': 'Volumetric Plaque Reduction', 'timeFrame': 'measured at time of procedure', 'description': 'Volumetric plaque reduction immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by IVUS. Actual volume of plaque present is presented for each measurement point.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Peripheral Artery Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and efficacy of the CLiRpath® Photoablation Atherectomy System consisting of the Bias Sheath guiding catheter, in combination with the available CLiRpath® Excimer Laser Catheters ≤ 2.0 mm, to create larger lumens for treatment within the superficial femoral and popliteal arteries above the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral Inclusion Criteria\n\n1. Peripheral vascular disease Rutherford Classification 1, 2, or 3;\n2. Eligible for revascularization of native vessel (PTA or bypass);\n3. Willing and able to comply with the specified evaluations during hospitalization and all required follow-up examinations;\n4. Written informed consent given before execution of study procedures; and\n5. Age \\> 18 and ≤ 85 years.\n\nAngiographic Inclusion Criteria\n\n1. Reference vessel diameter \\>/= 4.0 mm and ≤ 7.0 mm as determined by physician visual angiographic assessment of the most normally appearing vessel segment within 10 mm proximal AND 10 mm distal to the target segment.\n2. Stenosis within the SFA and/or popliteal artery above the knee of \\>/= 70% and \\</= 100% DS (occlusion), as determined by visual angiographic assessment by the investigator at the time of the procedure and documented by angiography in at least two (2) orthogonal views.\n3. At least 1.0 cm of visible SFA stump beyond the origin of the profunda artery.\n4. Total lesion length \\>/= 1.0 cm and ≤ 15.0 cm as determined by visual angiographic assessment at the time of the procedure, separate multiple lesions can be combined as two separate treatment areas as long as the sum total of all lesion lengths and/or treatment areas does not exceed 1.0 cm to 15.0 cm.\n5. Patency (\\< 50% DS) of at least one (1) infrapopliteal artery in continuity with the native femoropopliteal artery.\n\n \\-\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria\n\n1. Contraindication to intravenous contrast material, heparin, aspirin or other medications required for a percutaneous interventional procedure;\n2. Known bleeding or hyper-coagulation disorder;\n3. Serum creatinine \\> 2.0 mg/dL;\n4. Uncompensated congestive heart failure;\n5. Current enrollment in any investigational study wherein patient participation has not been completed;\n6. Prior enrollment in this study;\n7. Suspected or confirmed pregnancy;\n8. Any patient, who in the opinion of the investigator, would not be a good candidate for enrollment;\n9. Myocardial infarction within 60 days; and\n10. CVA/TIA within 60 days. Angiographic Exclusion Criteria\n\n1\\.\n\n1. Subintimal guidewire placement following pilot channel creation through a stenosis or occlusion with any excimer laser catheter, as visualized with IVUS;\n2. Calcification likely to prevent the passage of the excimer laser catheter or CLiRpath® Photoablation Atherectomy system;\n3. Ipsilateral and/or contralateral iliac stenosis \\>/= 50% DS that is not treated prior to enrollment in this study;\n4. Ipsilateral and/or contralateral iliac treatment of a stenosis prior to enrollment with final residual stenosis \\>/= 30%, as determined in at least two (2) orthogonal views and documented by angiography;\n5. Iliac treatment prior to enrollment where a perforation occurred requiring a covered stent, blood transfusion, or surgery for treatment of the perforation;\n6. Identification of any lesion above the knee and/or below the knee in the treated leg (ipsilateral) that will require preplanned or predicted treatment within six (6) months after enrollment and prior to the completion of the six (6) month follow-up, including the iliac artery, the common femoral artery, the peroneal, anterior tibial, or posterior tibial arteries, or any area from the iliacs to the foot outside of the treatment area;\n7. Lesions proximal and distal to the treatment site that are \\>/= 50% DS at time of enrollment;\n8. Contralateral leg disease that requires treatment within the next 30 days and prior to completion of the 30 day follow-up;\n9. Cardiovascular surgical or cardiovascular interventional procedures (including, but not limited to, aortic, renal, cardiac, carotid, femoro-popliteal, and below the knee) within 30 days prior to enrollment in this study;\n10. Planned or predicted cardiovascular surgical or interventional procedures outside of the ipsilateral leg (including, but not limited to aortic, renal, cardiac, carotid, contralateral femoro-popliteal, and contralateral below the knee) within 30 days after entry into this study, and prior to completion of the 30-day follow-up; and\n11. Perforation or dissection of grade "C" or greater seen during or after the creation of the pilot channel.'}, 'identificationModule': {'nctId': 'NCT00595959', 'acronym': 'CELLO', 'briefTitle': 'CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spectranetics Corporation'}, 'officialTitle': 'CLiRpath® Excimer Laser System to Enlarge Lumen Openings', 'orgStudyIdInfo': {'id': '9000-0001-03 CELLO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser Treatment', 'description': 'CLiRpath Photoablation Atherectomy System', 'interventionNames': ['Device: CLiRpath Photoablation System']}], 'interventions': [{'name': 'CLiRpath Photoablation System', 'type': 'DEVICE', 'description': 'Use of CLiRpath Laser Catheter to improve vessel lumen diameter.', 'armGroupLabels': ['Laser Treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Thomas M Rasmussen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Spectranetics Corp.'}, {'name': 'Rajesh Dave, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pinnacle Health Hospital, Central Pennsylvania Research Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spectranetics Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Rajesh M. Dave, M.D.', 'oldOrganization': 'Pinnacle Health Hospital, Central Pennsylvania Research Foundation'}}}}