Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-02-17 @ 9:41 PM
Study NCT ID:
NCT02720003
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2016-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'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': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-19', 'studyFirstSubmitDate': '2016-02-26', 'studyFirstSubmitQcDate': '2016-03-21', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year', 'timeFrame': '0-12 months', 'description': 'Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio \\[PSVR\\] ≥2.5 and/or abnormal waveforms, as determined by an Independent Core Laboratory) and freedom from target lesion revascularization (TLR).'}, {'measure': 'Primary Safety - Percentage of Subjects With Composite of Freedom From All-cause Peri-operative Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death', 'timeFrame': '0-30 days', 'description': 'Primary Safety - Percentage of Subjects With Composite of Freedom From All-cause Peri-operative Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death'}], 'secondaryOutcomes': [{'measure': 'Device Success', 'timeFrame': '1 month'}, {'measure': 'Technical Success', 'timeFrame': '1 month'}, {'measure': 'Acute Technical Success', 'timeFrame': '1 month'}, {'measure': 'Procedural Success', 'timeFrame': '1 month'}, {'measure': 'Percentage of Subjects with Primary Patency of the Target Lesion', 'timeFrame': '24 months'}, {'measure': 'Target Lesion Revascularization', 'timeFrame': '24 months', 'description': 'Proportion of subjects with target lesion revascularization through 24 months'}, {'measure': 'Change in Rutherford Classification', 'timeFrame': '24 months', 'description': 'Mean change in Rutherford Classification from baseline through 24 months'}, {'measure': 'Change in Ankle Brachial Index', 'timeFrame': '24 months', 'description': 'Mean change in ankle brachial index from baseline through 24 months'}, {'measure': 'Percentage of subjects who died from any cause', 'timeFrame': '24 months'}, {'measure': 'Amputation-free Survival', 'timeFrame': '24 months', 'description': 'Percentage of subjects with above-the-ankle amputation-free survival'}, {'measure': 'Percentage of subjects with Target Vessel Revascularization', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atherosclerosis', 'Superficial Femoral Artery', 'Proximal Popliteal Artery'], 'conditions': ['Femoral Artery Stenosis', 'Femoral Artery Occlusion', 'Stenosis of Popliteal Arteries', 'Occlusion of Popliteal Arteries']}, 'descriptionModule': {'briefSummary': 'To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion of the superficial femoral and popliteal arteries.', 'detailedDescription': 'The study will enroll patients presenting with claudication or ischemic rest pain due to stenotic lesions in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful pre-dilatation, subjects determined by the investigator not to require stenting based on defined angiographic criteria will receive the BARD LTX DCB. .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥18 and \\< 85 years of age;\n* Documented diagnosis of peripheral arterial disease (PAD) with Rutherford Classification stages 2-4;\n* Patient is willing to provide informed consent and comply with the required - follow up visits, testing schedule and medication regimen;\n\nAngiographic Criteria\n\n* Single lesion or up to two focal lesions (not separated by \\>3 cm) (total vessel segment length ≤20 cm) in native superficial femoral and/or popliteal arteries;\n* ≥70% diameter stenosis by visual estimate;\n* Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;\n* De novo lesion(s) or non-stented restenotic lesion(s) \\>90 days from prior angioplasty procedure;\n* Lesion is located at least 3 cm from any stent, if target vessel was previously stented;\n* Target vessel diameter between ≥4 and ≤7 mm and able to be treated with available device size matrix;\n* Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;\n* A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow iliac and/or common femoral artery lesions);\n* No vascular interventions, surgical or interventional procedures within 2 weeks before and/or planned 30 days after the protocol treatment.\n\nExclusion Criteria\n\nPatients will be excluded if ANY of the following conditions apply:\n\n* Breastfeeding or pregnant or planning on becoming pregnant or men intending to father children;\n* Life expectancy of \\< 2 year;\n* Patient is currently participating in an investigational drug or other device study or previously enrolled in this study;\n* History of stroke within 3 months;\n* History of MI, thrombolysis or angina within 2 weeks of enrollment;\n* Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/dL within 30 days of index procedure or treated with dialysis);\n* Diagnosed active systemic infection or uncontrolled coagulopathy within 14 days prior to index procedure\n* Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;\n* Inability to take required study medications or allergy to paclitaxel or paclitaxel related compounds or contrast that cannot be adequately managed with pre- and post-procedure medication;\n* The lesion is a post-DCB restenosis, or within or adjacent to an aneurysm; Ipsilateral retrograde access;\n* There is no normal proximal arterial segment in which duplex flow velocity can be measured;\n* Known inadequate distal outflow (≥50% stenosis of distal popliteal and/or all three tibial vessels;), or planned future treatment of vascular disease distal to the target lesion;\n* Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;\n* Severe calcification that renders the lesion un-dilatable or failed pre-dilatation, defined by a residual stenosis \\>50% or major flow limiting dissection;\n* Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, embolic protection device, etc.).'}, 'identificationModule': {'nctId': 'NCT02720003', 'briefTitle': 'A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'A Prospective, Multicenter, Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries (LEVANT China)', 'orgStudyIdInfo': {'id': 'BC1401PV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LTX DCB', 'description': 'Patients treated with Bard Lutonix DCB', 'interventionNames': ['Device: LTX DCB']}], 'interventions': [{'name': 'LTX DCB', 'type': 'DEVICE', 'description': 'Treatment with a drug-coated balloon', 'armGroupLabels': ['LTX DCB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100038', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Shijitan Hospital. CMU', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese- PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510260', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '116011', 'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Affiliated Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '266003', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'The Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '200011', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Ninth People's Hosptial , Shanghai JiaoTong University School of Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'RENJI Hospital Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'General Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Wei Guo, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}, {'name': 'Weiguo Fu, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}, {'name': 'Fuxian Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Shijitan Hospital. CMU'}, {'name': 'Tong Qiao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, {'name': 'Lan Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}, {'name': 'Xinwu Lu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai Ninth People's Hosptial , Shanghai JiaoTong University School of Medicine"}, {'name': 'Feng Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Dalian Medical University'}, {'name': 'Pingfan Guo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Fujian Medical University'}, {'name': 'Shaomang Lin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Guangzhou Medical University'}, {'name': 'Wei Bi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Hebei Medical University'}, {'name': 'Jichun Zhao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}, {'name': 'Jianjun Jiang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}, {'name': 'Haofu Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Hospital of Qingdao University'}, {'name': 'Xiangchen Dai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}