Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT05662618
Status:
UNKNOWN
Last Update Posted:
2022-12-22
First Post:
2022-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 276}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-14', 'studyFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2022-12-14', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence rate of major adverse events', 'timeFrame': '12 months after operation.', 'description': 'Major adverse events were defined as: all cause death at 30 days, amputation of diseased limbs 12 months after operation, and clinically driven target vessel revascularization'}, {'measure': 'Occurrence of other adverse events and serious adverse events', 'timeFrame': '12 months after operation.', 'description': 'Evaluation method: other adverse events and serious adverse events of the subjects were recorded through telephone/hospital visit.'}], 'primaryOutcomes': [{'measure': 'primary patency rate, PPR.', 'timeFrame': '12months', 'description': 'It is defined as:Primary patency of target lesion: the target lesion is patency (systolic peak blood flow ratio\\<2.4) and there is no clinically driven target lesion revascularization (TLR) by Doppler ultrasound.'}], 'secondaryOutcomes': [{'measure': 'Device success rate', 'timeFrame': 'The day of operation.', 'description': 'It is defined as: the balloon catheter can reach the target lesion, expand successfully, without rupture, and withdraw successfully.'}, {'measure': 'Operation success rate', 'timeFrame': '1DAY', 'description': 'The success of surgery was defined as: residual stenosis ≤ 50% (without salvage stent implantation) or ≤ 30% (with salvage stent implantation).'}, {'measure': 'Target Lesion Revascularization incidence.', 'timeFrame': '12 months after operation.', 'description': 'Target Lesion Revascularization is defined as any re intervention treatment required in the target lesion.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'A prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with arteriosclerosis obliterans of lower extremities, and Rutherford's rating is 2-5.\n* Patients with severe stenosis (≥ 70%) or occlusion of superficial femoral artery and/or proximal popliteal artery (within P1 stage)\n* Patients with total length of target lesion ≤ 20cm and length of occluded segment ≤ 15cm (the distance between two segments of lesions less than 2cm is considered as the same lesion)\n* Those who agree to participate in this clinical trial and sign the informed consent form Exclusion criteria：\n* This operation is planned to intervene patients with bilateral lower limbs.\n* Patients whose guide wire fails to pass through the target lesion.\n* Patients whose target lesion is in stent restenosis (ISR).\n* ≥ 2 lesions need to be treated in the target vessel (if the distance between two lesions is less than 2cm, it is considered as the same lesion).\n* Patients with target lesions requiring rotary resection/laser therapy/thrombus aspiration for this treatment.\n* Patients with ipsilateral iliac artery inflow tract lesions that cannot be successfully treated (i.e. residual stenosis ≥ 30% after treatment).\n* There is less than one unobstructed blood vessel under the knee of the target limb before operation (unobstructed is defined as visual stenosis\\<50%).\n* Residual stenosis ≥ 30% after pre expansion of target lesion or severe (≥ Grade D) flow limiting dissection.\n* Patients with obviously abnormal renal function (creatinine \\> 2.5mg/dL or 220umol/L) or undergoing dialysis.\n* Patients with severe liver dysfunction who are judged by the researcher to be unsuitable for surgery.\n* Patients with severe coagulation dysfunction or uncontrolled severe infection who are not suitable for surgery.\n* Patients who have performed distal amputation (above metatarsal) on the affected or opposite limb in the past.\n* Patients who received local or systemic thrombolytic therapy within 48 hours before surgery.\n* Patients receiving vascular interventional therapy or surgical treatment on target limb within 30 days before operation.\n* Patients known to be allergic to aspirin, clopidogrel, paclitaxel and rapamycin.\n* Pregnant or lactating women and patients with family planning during the study\n* Patients who are participating in clinical trials of other drugs or medical devices but are not included in the group.\n* Patients with life expectancy less than 12 months\n* Patients not suitable for this study."}, 'identificationModule': {'nctId': 'NCT05662618', 'briefTitle': 'To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Bomaian Medical Technology Co., Ltd'}, 'officialTitle': 'Prospective, Multicenter, Randomized Controlled Clinical Trial to Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease', 'orgStudyIdInfo': {'id': 'LFBMA-202201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapamycin coated peripheral balloon catheter', 'description': 'Rapamycin coated peripheral balloon catheter of Bomaian Company.', 'interventionNames': ['Procedure: Percutaneous selective arteriography of peripheral arteries']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Drug eluting peripheral balloon catheter', 'description': 'Paclitaxel eluting balloon catheter', 'interventionNames': ['Procedure: Percutaneous selective arteriography of peripheral arteries']}], 'interventions': [{'name': 'Percutaneous selective arteriography of peripheral arteries', 'type': 'PROCEDURE', 'description': 'Treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery with rapamycin coated balloon catheter.', 'armGroupLabels': ['Drug eluting peripheral balloon catheter', 'Rapamycin coated peripheral balloon catheter']}, {'name': 'Percutaneous selective arteriography of peripheral arteries', 'type': 'PROCEDURE', 'description': 'Paclitaxel coated balloon catheter for the treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery.', 'armGroupLabels': ['Drug eluting peripheral balloon catheter', 'Rapamycin coated peripheral balloon catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Wei Guo', 'role': 'CONTACT', 'email': 'Pla301dml@vip.sina.com', 'phone': '010-66887329'}], 'facility': "The First Medical Center of the General Hospital of the Chinese People's Liberation Army", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wei Guo', 'role': 'CONTACT', 'email': 'Pla301dml@vip.sina.com', 'phone': '010-66887329'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Bomaian Medical Technology Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}