Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-02 @ 6:38 AM
Study NCT ID:
NCT03589157
Status:
UNKNOWN
Last Update Posted:
2018-07-17
First Post:
2018-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Safety and Efficacy of Coronary Drug-coated Balloon (DCB) Combined With Spot Stenting of Drug-eluting Stent (DES) Versus Second-generation DES for Treating Diffuse Coronary Artery Lesions: a Prospective, Randomized, Controlled Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2018-07-05', 'studyFirstSubmitQcDate': '2018-07-16', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late lumen loss', 'timeFrame': '9 months', 'description': 'Late lumen loss (LLL) in the lesion segment within 9 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Interventional therapy success rate', 'timeFrame': '3 years', 'description': 'including device success rate, lesion success rate and clinical success rate'}, {'measure': 'Restenosis rate (RR) in the lesion segment', 'timeFrame': '9 months', 'description': 'Restenosis rate (RR) in the lesion segment on 9 months after operation'}, {'measure': 'Clinically-driven target lesion revascularization', 'timeFrame': '3 years', 'description': 'Clinically-driven target lesion revascularization (CD-TLR) at 30 days and 3, 6, 9, 12, 24 and 36 months postoperatively'}, {'measure': 'Device-related cardiovascular clinical composite endpoints', 'timeFrame': '3 years', 'description': 'including cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization (CD-TLR), called target lesion failure (TLF) for short'}, {'measure': 'Patient-related cardiovascular clinical composite endpoints', 'timeFrame': '3 years', 'description': 'including all-cause mortality, all myocardial infarctions, and any revascularization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Coronary Artery Lesions']}, 'descriptionModule': {'briefSummary': 'The prospective, randomized, controlled clinical trial aims to evaluate the safety and efficacy of paclitaxel-eluting PTCA-balloon catheter (SeQuent® Please) combined with provisional spot stenting of DES versus DES for treating diffuse coronary artery lesions concerning interventional therapy and vessel patency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient-related\n\n * Patients who have typical angina pectoris symptoms with obvious evidence of ischemia;\n * Patients whose ages are between 18-80 years;\n * Patients who must agree to receive a 9-month angiographic follow-up;\n * Patients who must agree to receive clinical follow-up of 30 days, and 3, 6, 9, 12, 24 and 36 months;\n * Patients who can understand the purpose of this study both psychologically and linguistically, demonstrating sufficient compliance to the study protocol;\n * Patients who express their recognition of the risks and benefits described in the informed consent form by providing their inform consent;\n* Lesion-related\n\n * Diffuse coronary artery disease in situ;\n * Reference target vessel diameter of 2.5-4.0 mm and length of \\> 25 mm;\n * Non-target vessel lesions needing to receive a successful intervention therapy first before randomization to receive treatment for target lesions (note: within the same hospitalization);\n * Visually estimated diameter stenosis of ≥70%, or diameter stenosis of ≥50% with objective evidences of ischemia (treadmill exercise testing, ECT or FFR\\<0.8)\n\nExclusion Criteria:\n\n* Patient-related:\n\n * Patients who have the attack of myocardial infarction within the past week, or whose troponin fails to return to normal although myocardial infarction has occurred for over one week;\n * Patients with serious congestive heart failure or NYHA IV-level serious heart failure;\n * Patients whose left ventricular ejection fraction is \\< 30%;\n * Patients who have medical history of stroke or TIA within 6 months prior to the surgery;\n * Patients who have a current or previous history of serious liver failure and thereby fail to meet the requirements of angiography;\n * Patients who have a current or previous history of serious kidney failure (GFR\\<30 ml/min) and thereby fail to meet the requirements of angiography;\n * Patients who have a previous history of intracranial neoplasms, aneurysm, arteriovenous malformation or cerebral hemorrhage;\n * Patients whose life expectancy does not exceed 1 year or who are difficult to follow up clinically;\n * Patients who have been scheduled to undergo elective surgery which may lead to the early discontinuation of ADP receptor antagonists;\n * Pregnant or lactating women or women who are planning to become pregnant during the study.\n * Patients participating in any other clinical trial;\n * Patients who are considered not suitable for inclusion by the investigator for any other reason;\n* Lesion-related:\n\n * Patients who have the evidence of extensive thrombosis in target vessels prior to the interventional therapy;\n * Patients who have left main coronary artery disease or graft lesions needing to be treated;\n * Patients who have bifurcation lesions with a side-branch vessel diameter of \\>2.5 mm;\n * Patients who have lesions at the ostia of coronary artery, at the circumflex branch, at the ostia of anterior descending branch or within 5 mm at the ostia of coronary artery;\n * Severe intimal tear disease;\n * In-stent restenosis;\n * Lesions which can not be treated with PTCA or other intervention technologies;\n * Lesions with serious calcification;\n* Concomitant medication related\n\n * Patients who have a physique prone to hemorrhage and are prohibited from taking anticoagulants or antiplatelet drugs;\n * Patients who can not tolerate Aspirin and/or Clopidogrel, or who have serious hypohepatia and must not use Clopidogrel;\n * Patients who can not tolerate or have known allergy to heparin, contrast media, paclitaxel, iopromide, rapamycin, poly(lactic-co-glycolic acid) polymers or stainless steel, etc,;\n * Patients with a history of leukopenia (with WBC\\<3×109/L for more than 3 days), neutropenia (with ANC \\<1,000 cells/mm3 for more than 3 days), or thrombocytopenia (with platelet count \\<100,000/mm3);'}, 'identificationModule': {'nctId': 'NCT03589157', 'briefTitle': 'Comparison of Safety and Efficacy of Coronary Drug-coated Balloon (DCB) Combined With Spot Stenting of Drug-eluting Stent (DES) Versus Second-generation DES for Treating Diffuse Coronary Artery Lesions: a Prospective, Randomized, Controlled Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Comparison of Safety and Efficacy of Coronary Drug-coated Balloon (DCB) Combined With Spot Stenting of Drug-eluting Stent (DES) Versus Second-generation DES for Treating Diffuse Coronary Artery Lesions: a Prospective, Randomized, Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'AAG-G-H-1518'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug-coated balloon group', 'interventionNames': ['Device: drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'second-generation drug-eluting stent group', 'interventionNames': ['Device: drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)']}], 'interventions': [{'name': 'drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES)', 'type': 'DEVICE', 'description': 'using drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) for treating diffuse coronary artery lesions', 'armGroupLabels': ['Drug-coated balloon group']}, {'name': 'drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)', 'type': 'DEVICE', 'description': 'using drug-coated balloon (DCB) combined with second-generation DES for treating diffuse coronary artery lesions', 'armGroupLabels': ['second-generation drug-eluting stent group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gao Lei, MD', 'role': 'CONTACT', 'email': 'nkgaolei2010@126.com', 'phone': '13661022415'}], 'overallOfficials': [{'name': 'Yundai Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yun Dai Chen', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}