Clinical trial NCT03589157: 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
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diffuse Coronary Artery Lesions
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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);

Primary outcomes:
measure: Late lumen loss
timeFrame: 9 months
Secondary outcomes:
measure: Interventional therapy success rate
timeFrame: 3 years
measure: Restenosis rate (RR) in the lesion segment
timeFrame: 9 months
measure: Clinically-driven target lesion revascularization
timeFrame: 3 years
measure: Device-related cardiovascular clinical composite endpoints
timeFrame: 3 years
measure: Patient-related cardiovascular clinical composite endpoints
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Chinese PLA General Hospital
name: Yundai Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: