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

Not Applicable

• Conditions: Diffuse Coronary Artery Lesions

• Registration Number: NCT03589157
• Lead Sponsor: Chinese PLA General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-05
• Study Start: 2018-07-15
• Study First Submitted QC: 2018-07-16
• Last Update Submitted: 2018-07-16
• Study First Posted: 2018-07-17
• Last Update Posted: 2018-07-17
• Primary Completion: 2021-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Late lumen loss	9 months	Late lumen loss (LLL) in the lesion segment within 9 months after surgery

Secondary Outcome Measures

Name	Time	Method
Interventional therapy success rate	3 years	including device success rate, lesion success rate and clinical success rate
Clinically-driven target lesion revascularization	3 years	Clinically-driven target lesion revascularization (CD-TLR) at 30 days and 3, 6, 9, 12, 24 and 36 months postoperatively
Device-related cardiovascular clinical composite endpoints	3 years	including cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization (CD-TLR), called target lesion failure (TLF) for short
Patient-related cardiovascular clinical composite endpoints	3 years	including all-cause mortality, all myocardial infarctions, and any revascularization
Restenosis rate (RR) in the lesion segment	9 months	Restenosis rate (RR) in the lesion segment on 9 months after operation