STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial

China National Center for Cardiovascular Diseases1 site in 1 country2,700 target enrollmentOctober 15, 2023

ConditionsDrug-coated Balloon Drug-eluting Stent De Novo Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Drug-coated Balloon
Sponsor: China National Center for Cardiovascular Diseases
Enrollment: 2700
Locations: 1
Primary Endpoint: Incidence of a composite of cardiac death, target-vessel myocardial infarction and clinically indicated target vessel revascularization
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, open-label, randomized controlled study meant to compare the safety and efficacy of scheduled drug-coated balloon (DCB) and conventional drug-eluting stent (DES) strategy in the treatment of de novo lesions of large coronary vessel with diameter larger than 2.75 mm. The trial was designed to provide high-quality evidence for expanding the clinical indications of DCB, and to explore a better way for coronary intervention based on DCB.

Registry

clinicaltrials.gov

Start Date

October 15, 2023

End Date

December 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

China National Center for Cardiovascular Diseases

Responsible Party

Principal Investigator

Yongjian Wu, MD, PhD

Director of Coronary Heart Disease Center

China National Center for Cardiovascular Diseases

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years
•De novo lesions of large coronary vessels with the diameter of target lesion reference vessel \> 2.75 mm
•Single- or multi-vessel disease with only 1 lesion meeting the definition of severe stenosis and anatomically amenable to coronary revascularization using DCB alone judged by physician.
•Severe stenosis is defined if 1 of the following criteria are met:
•visual angiographic stenosis with severity \>= 70%.
•functional stenosis with quantitative flow reserve (QFR) or fractional flow reserve (FFR) \< 0.
•Other coronary artery lesions are not recommended for coronary revascularization by current guidelines and are not likely need to be treated within the next 1 year judged by physician (e.g., visual stenosis with severity between 50-70% and FFR \> 0.8)
•The prospective subject is agreed on participating the study with a formal written consent

Exclusion Criteria

•History of acute coronary syndrome within the last 6 months.
•Acute coronary syndrome is defined as 1 of following diagnosis:
•Unstable Angina Pectoris (UAP)
•ST-Elevated Myocardial Infarction (STEMI)
•Non-ST-Elevated Myocardial Infarction (NSTEMI)
•Diagnosis of myocardial infarction (MI) requires both clinical evidence of myocardial ischemia and elevation of cardiac Troponin (cTn) I or T values with at least 1 value above the 99th percentile upper normal range limit (URL)
•Clinical evidence of myocardial ischemia is defined as 1 of the following:
•Symptoms of myocardial ischemia
•New ischemic ECG changes
•Development of pathological Q waves

Outcomes

Primary Outcomes

Incidence of a composite of cardiac death, target-vessel myocardial infarction and clinically indicated target vessel revascularization

Time Frame: 12 months

Incidence of a composite of cardiac death, target-vessel myocardial infarction and clinically indicated target vessel revascularization

Secondary Outcomes

Incidence of a composite of peri-procedural complications including cardiac death, perioperative myocardial infarction, acute thrombosis at target vessel and acute occlusion at target vessel(30 days)
Incidence of target-vessel myocardial infarction(12 months)
Score of EuroQol Five Dimensions-5L (EQ-5D-5L)(1, 6 and 12 months)
Quality-adjusted life-years (QALYs)(12 months)
Total costs(12 months)
Incidence of cardiac death(12 months)
Incidence of clinically indicated target vessel revascularization(12 months)
Incidence of a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and re-hospitalization(12 months)
Incidence of major bleeding (Bleeding Academic Research Consortium [BARC] definition, type 2 to 5)(12 months)
Score of Seattle Angina Questionnaire (SAQ)(1, 6 and 12 months)
Incidence of net clinical benefit (a composite of cardiac death, target-vessel myocardial infarction, clinically indicated target vessel revascularization and major bleeding)(12 months)
Incremental cost-effectiveness ratios (ICER)(12 months)