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

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.

Study Overview

• Status: Unknown
• Conditions: Diffuse Coronary Artery Lesions
• Intervention / Treatment: Device: drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES); Device: drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Drug-coated balloon group	Device: 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
ACTIVE_COMPARATOR: second-generation drug-eluting stent group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late lumen loss	Late lumen loss (LLL) in the lesion segment within 9 months after surgery	9 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 15, 2018
• Primary Completion (ANTICIPATED): June 30, 2021
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (ACTUAL): July 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: AAG-G-H-1518

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No