Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-24 @ 4:54 PM
Study NCT ID:
NCT01746550
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2012-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Effectiveness Study of the MD-12-001 Stent in the Treatment of Superficial Femoral Artery or Popliteal Artery Blockages in Japanese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2012-12-07', 'studyFirstSubmitQcDate': '2012-12-10', 'lastUpdatePostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of subjects who are free of target limb failure at 12-months post study procedure.', 'timeFrame': '12-months post study procedure'}], 'secondaryOutcomes': [{'measure': 'The proportion of subjects who are free of target limb failure.', 'timeFrame': '30-days, 6-, 24-, and 36-months post study procedure'}, {'measure': 'The proportion of subjects with primary target lesion patency.', 'timeFrame': '30-days, 6-, 12-, 24-, and 36-months post study procedure', 'description': 'This endpoint will assess whether the study blockage has been unblocked using ultrasound imaging assessments reviewed by an independent core laboratory.'}, {'measure': 'The proportion of subjects with secondary target vessel/lesion patency.', 'timeFrame': '30-days, 6-, 12-, 24-, and 36-months post study procedure', 'description': 'This endpoint will assess whether the study blockage has shut again; where the target vessel/lesion no longer has blood flow or where surgical bypass of the vessel is performed.'}, {'measure': 'Proportion of subjects who achieve acute procedural success.', 'timeFrame': 'Perioperative period (period during study procedure)'}, {'measure': 'Rutherford category assessment.', 'timeFrame': 'Baseline, 30-days. 3-. 6-. 12-. 24-. 36-. 48- and 60-months post study procedure', 'description': 'The assessment of peripheral artery disease severity will be performed using the Rutherford Classification system.'}, {'measure': 'Ankle-brachial index measurements.', 'timeFrame': 'Baseline, 30-days, 3-, 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure', 'description': 'The ratio of blood pressure in the lower legs to the blood pressure in the arms will be calculated and assessed as a measure of disease severity.'}, {'measure': 'Quality of Life (SF-36) Questionnaire', 'timeFrame': 'Baseline, 30-days, 3- , 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure', 'description': 'The SF-36 Quality of Life Questionnaire (QOL) will be used to evaluate QOL changes during study participation.'}, {'measure': 'Proportion of Subjects who experience Major Adverse Events.', 'timeFrame': '30-days post procedure', 'description': 'Major Adverse Events is defined as any death, stroke, myocardial infarction (heart attack) or target limb amputation.'}, {'measure': 'Proportions of Subjects who experience 1) any adverse event and 2) any serious adverse event.', 'timeFrame': 'through 60-months post study procedure'}, {'measure': 'The proportion of subjects who undergo target vessel/lesion revascularization (restoration of blood flow)', 'timeFrame': '12-, 24-, 36-, 48-, and 60-months post study procedure'}, {'measure': 'Proportion of subjects without stent fracture', 'timeFrame': '30-days, 6-, 12-, 24, and 36-months post study procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arterial Occlusive Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and effectiveness of the MD-12-001 stent in the treatment of superficial femoral artery and proximal popliteal artery blockages in Japanese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Rutherford Category 2-4 (mild intermittent claudication (pain while walking)to ischemic pain (pain due to decreased blood flow) at rest).\n* The target lesion(s) has evidence of narrowing or blockage and can be stented.\n* The total length of the lesion or series of lesions is estimated to be less than or equal to 150 mm.\n* The target vessel reference diameter is greater than or equal to 4.0 mm and less than or equal to 6.5 mm\n\nKey Exclusion Criteria:\n\n* The subject has a known reaction (including allergic reaction) or sensitivity to blood thinning medications, or study device materials (nickel, titanium or tantalum)\n* The subject has a known sensitivity to medical imaging substances (contract media) that cannot be pretreated with medications (steroids or/and antihistamines)\n* The subject has a history of bleeding disorders (diatheses or coagulopathy).\n* The subject has kidney failure or is having dialysis treatment.\n* The subject has insufficient liver function, swelling of vein(s) caused by blood clot (thrombophlebitis), uremia, systemic lupus, or deep vein blood clots.\n* Subject has Acute Limb Ischemia (a sudden loss of blood flow to the limb).\n* Subject has a history of bypass surgery on the study vessel.\n* Subject has a history of heart attack or stroke within 6 months of study procedure.\n* The subject is receiving immunosuppressive therapy (medications that lower the body's normal immune response).\n* The subject is diagnosed with a severe infection (septicemia).\n* Principal investigator determines the subject's condition would prevent the subject from undergoing the study procedure or cannot support a vascular bypass graft.\n* The subject with a stent previously implanted into the target vessel.\n* Subject has disease in both legs where both limbs meet the inclusion criteria and it is planned to treat both limbs within 30 days.\n* Pregnant, possibly pregnant and/or nursing female subjects are excluded, as are female subjects who are willing to have a baby during the trial.\n* The subject is participating in an investigational drug or another investigational device study.\n* Subject has a large amount of blood clot next to the study lesion."}, 'identificationModule': {'nctId': 'NCT01746550', 'acronym': 'Reliable', 'briefTitle': 'A Safety and Effectiveness Study of the MD-12-001 Stent in the Treatment of Superficial Femoral Artery or Popliteal Artery Blockages in Japanese Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'A Single Arm Clinical Trial in Japan for Reconstruction of Obstructive Lesions of the Superficial Femoral Artery or Proximal Popliteal Artery by Bard LifeStent.', 'orgStudyIdInfo': {'id': 'MED-12-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MD-12-001 Stent Arm', 'description': 'This study includes a single arm, the MD-12-001 Stent Arm.', 'interventionNames': ['Device: MD-12-001 Stent']}], 'interventions': [{'name': 'MD-12-001 Stent', 'type': 'DEVICE', 'otherNames': ['Bard Lifestent Vascular Stent'], 'description': 'MD-12-001 is a self-expanding nitinol stent', 'armGroupLabels': ['MD-12-001 Stent Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kokura Kinen', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Tokeidai Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Amagasaki', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kansai Rosai Hospital', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'city': 'Kamakura', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Shonankamakura General Hospital', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Saiseikai Yokohamashi Tobu Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Sendai Kousei Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Kashihara', 'state': 'Nara', 'country': 'Japan', 'facility': 'Nara Medical University Hospital', 'geoPoint': {'lat': 33.95, 'lon': 135.78333}}, {'city': 'Kishiwada', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kishiwada Tokushukai Hospital', 'geoPoint': {'lat': 34.46667, 'lon': 135.36667}}, {'city': 'Kasukabe', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Kasukabe Chuo General Hospital', 'geoPoint': {'lat': 35.98308, 'lon': 139.74966}}, {'city': 'Meguro City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Toho University Ohashi Hospital', 'geoPoint': {'lat': 35.6322, 'lon': 139.70174}}, {'city': 'Minato', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'The Jikei University Hospital', 'geoPoint': {'lat': 35.6581, 'lon': 139.7515}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Kyushu University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], 'overallOfficials': [{'name': 'Masato Nakamura', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toho University Ohashi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medicon, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}