Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-04-23 @ 10:23 PM
Study NCT ID:
NCT02891018
Status:
UNKNOWN
Last Update Posted:
2016-09-09
First Post:
2016-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter in the Treatment of In-stent Restenosis of Coronary Artery Lesion With Paclitaxel Release Coronary Balloon Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'lastUpdateSubmitDate': '2016-09-07', 'studyFirstSubmitDate': '2016-08-31', 'studyFirstSubmitQcDate': '2016-08-31', 'lastUpdatePostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late Lumen Loss', 'timeFrame': 'at 9 months'}], 'secondaryOutcomes': [{'measure': 'Device Success Rate', 'timeFrame': 'at 9 months'}, {'measure': 'Operation Success Rate', 'timeFrame': 'at 9 months'}, {'measure': 'Target lesion in-segment rate after operation 9 months', 'timeFrame': 'at 9 months'}, {'measure': 'Target lesion revascularization (TLR) and Target vessel revascularization (TVR) by clinical-driven', 'timeFrame': 'at 9 months'}, {'measure': 'Major adverse cardiovascular events (MACE) related with device, include cardiac death, myocardial infarction of target vessel and target lesion revascularization (TLR) by clinical-driven', 'timeFrame': 'at 9 months'}, {'measure': 'Thrombotic events incidence (ARC definition include deterministic thrombosis, possible thrombosis and not eliminating thrombosis; point-in-time include acute within 24h, subacute between 2 and 30 d and later period over 30 d)', 'timeFrame': 'at 9 months'}]}, 'conditionsModule': {'conditions': ['In-stent Restenosis']}, 'descriptionModule': {'briefSummary': 'Study purpose The safety and efficacy of paclitaxel controlled release balloon catheter Vasoguard TM in treatment of in-stent restenosis.\n\nStudy group Experimental group: paclitaxel controlled release balloon catheter Vasoguard TM Control group: paclitaxel release coronary balloon catheter SeQuent Please'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Subject need 18 to 80 years of aged male or non-pregnant women; Subject has stable anina pectoris, or unstable anina pectoris, or old myocardial infarction patients, or ischemia with evidence but without symptom; Subject has a life expectancy of more than 2 years; Subject occurred restenosis after vessel lesion in situ receiving the first stent operation; In-stent restenosis type Mehran I, II, III, IV, reference vessel diameter of 1.5-4.0 mm, length of 40 mm or less; Target lesion stenosis must be equal or greater than 70% or 50% and with evidence of ischemia; Single or two coronary small vessel lesions in situ; Other lesion which need interventional treatment must be away from target lesion at least 10 mm; Subject can understand the trail purpose, sign informed consent voluntarily, agree to accept clinical telephone follow-up and angiographic follow-up at 9 months; Target lesion can be pre-expanded successfully (Guide wire can get through lesion, balloon pre-expand the remnant stenosis of vessel lumen is less or equal to 50%, without current limiting interlayer and thrombosis).\n\nExclusion Criteria:\n\n\\- Patient that in the opinion of the investigator is not appropriate for this trail; Pregnancy and lactation female patients; Patient has a life expectancy of less than 2 years; Severe congestive heart failure or NYHA IV heart failure; Patient who have bleeding constitution, cannot use anticoagulation and antiplatelet drugs; Patient that happened acute myocardial infarction within a week; Patient who happened stroke within six months; Patient who with severe renal failure (GFR≤30ml/min); Patient who had received heart transplantation; Patient who cannot tolerate aspirin and / or P2Y12 receptor inhibitor drugs; Patient who has allergy to paclitaxel, PLGA or contrast agent; Peptic ulcer or gastrointestinal bleeding within the prior 6 months. Patients who are participating in another drug or device clinical trail, which have not completed the primary endpoint follow- up period.\n\nAngiographic relevant： Three or more coronary artery vessel lesion; Target vessel has extensive thrombosis evidence; Restenosis of vein graft after bypass surgery; Left main coronary artery and ostial lesion within 2mm; Target lesion proximal exist seriously distorted or severe calcified lesion.'}, 'identificationModule': {'nctId': 'NCT02891018', 'briefTitle': 'Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter in the Treatment of In-stent Restenosis of Coronary Artery Lesion With Paclitaxel Release Coronary Balloon Catheter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Branden Med.Device Co.,Ltd'}, 'officialTitle': 'A Multicenter, Prospective and Randomized Controlled Clinical Study (VasoguardTM Trial II) That Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter (VasoguardTM) in the Treatment of In-stent Restenosis of Coronary Artery Lesion With Paclitaxel Release Coronary Balloon Catheter (SeQuent Please)', 'orgStudyIdInfo': {'id': 'Branden-123456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'paclitaxel controlled release balloon catheter', 'description': 'Patients treated with paclitaxel controlled release balloon catheter', 'interventionNames': ['Device: paclitaxel controlled release balloon catheter Vasoguard TM']}, {'type': 'EXPERIMENTAL', 'label': 'paclitaxel release coronary balloon catheter', 'description': 'Patients treated with paclitaxel release coronary balloon catheter', 'interventionNames': ['Device: paclitaxel release coronary balloon catheter SeQuent Please']}], 'interventions': [{'name': 'paclitaxel controlled release balloon catheter Vasoguard TM', 'type': 'DEVICE', 'armGroupLabels': ['paclitaxel controlled release balloon catheter']}, {'name': 'paclitaxel release coronary balloon catheter SeQuent Please', 'type': 'DEVICE', 'armGroupLabels': ['paclitaxel release coronary balloon catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junbo Ge', 'role': 'CONTACT', 'phone': '13901977506'}], 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yuxia Yin', 'role': 'CONTACT', 'email': 'yinyx@brandentech.com', 'phone': '18596253015'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Branden Med.Device Co.,Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fudan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}