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

NCT ID: NCT03589157

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-15
• Study Completion Date: 2022-06-30

Brief Summary

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.

Conditions

Diffuse Coronary Artery Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Drug-coated balloon group

Group Type: EXPERIMENTAL

drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES)

Intervention Type: DEVICE

using drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) for treating diffuse coronary artery lesions

second-generation drug-eluting stent group

Group Type: ACTIVE_COMPARATOR

drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)

Intervention Type: DEVICE

using drug-coated balloon (DCB) combined with second-generation DES for treating diffuse coronary artery lesions

Interventions

drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES)

using drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) for treating diffuse coronary artery lesions

Intervention Type: DEVICE

drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)

using drug-coated balloon (DCB) combined with second-generation DES for treating diffuse coronary artery lesions

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient-related

• Patients who have typical angina pectoris symptoms with obvious evidence of ischemia;
• Patients whose ages are between 18-80 years;
• Patients who must agree to receive a 9-month angiographic follow-up;
• Patients who must agree to receive clinical follow-up of 30 days, and 3, 6, 9, 12, 24 and 36 months;
• Patients who can understand the purpose of this study both psychologically and linguistically, demonstrating sufficient compliance to the study protocol;
• Patients who express their recognition of the risks and benefits described in the informed consent form by providing their inform consent;
• Lesion-related

• Diffuse coronary artery disease in situ;
• Reference target vessel diameter of 2.5-4.0 mm and length of > 25 mm;
• 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);
• Visually estimated diameter stenosis of ≥70%, or diameter stenosis of ≥50% with objective evidences of ischemia (treadmill exercise testing, ECT or FFR<0.8)

Exclusion Criteria

• Patient-related:

• 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;
• Patients with serious congestive heart failure or NYHA IV-level serious heart failure;
• Patients whose left ventricular ejection fraction is < 30%;
• Patients who have medical history of stroke or TIA within 6 months prior to the surgery;
• Patients who have a current or previous history of serious liver failure and thereby fail to meet the requirements of angiography;
• 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;
• Patients who have a previous history of intracranial neoplasms, aneurysm, arteriovenous malformation or cerebral hemorrhage;
• Patients whose life expectancy does not exceed 1 year or who are difficult to follow up clinically;
• Patients who have been scheduled to undergo elective surgery which may lead to the early discontinuation of ADP receptor antagonists;
• Pregnant or lactating women or women who are planning to become pregnant during the study.
• Patients participating in any other clinical trial;
• Patients who are considered not suitable for inclusion by the investigator for any other reason;
• Lesion-related:

• Patients who have the evidence of extensive thrombosis in target vessels prior to the interventional therapy;
• Patients who have left main coronary artery disease or graft lesions needing to be treated;
• Patients who have bifurcation lesions with a side-branch vessel diameter of >2.5 mm;
• 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;
• Severe intimal tear disease;
• In-stent restenosis;
• Lesions which can not be treated with PTCA or other intervention technologies;
• Lesions with serious calcification;
• Concomitant medication related

• Patients who have a physique prone to hemorrhage and are prohibited from taking anticoagulants or antiplatelet drugs;
• Patients who can not tolerate Aspirin and/or Clopidogrel, or who have serious hypohepatia and must not use Clopidogrel;
• 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,;
• 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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yun Dai Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yundai Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Central Contacts

Gao Lei, MD

Role: CONTACT

nkgaolei2010@126.com

13661022415

Other Identifiers

AAG-G-H-1518

Identifier Type: -

Identifier Source: org_study_id