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

NCT06084000 | Unknown

• 1 other identifier: 2023-I2M-1-002
• Study Type: interventional
• Target: 2,700
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-coated Balloon; Drug-eluting Stent; De Novo Stenosis

Outcome Measures

Primary Outcomes (1)

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

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

  12 months

Secondary Outcomes (12)

• 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 cardiac death

  12 months

• Incidence of target-vessel myocardial infarction

  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

Study Arms (2)

Drug-coated balloon dominant strategy

EXPERIMENTAL

* Patients will receive DCB (Bingo©, Yinyi Ltd., China) only if pre-dilation of the lesion was successful, or otherwise receive bailout stenting. * If bailout stenting is indicated, patients will receive any type of commercially available 2nd Gen DES at physician's preference.

Device: Drug-coated balloon (Bingo© [Paclitaxel-coated Balloon], Yinyi Ltd., China)

Drug-eluting stent only strategy

ACTIVE COMPARATOR

-For conventional stenting, patients will receive any type of commercially available 2nd Gen DES at physician's preference.

Device: Drug-eluting stent

Interventions

Drug-coated balloon (Bingo© [Paclitaxel-coated Balloon], Yinyi Ltd., China) DEVICE

* Patients treated with DCB will receive dual antiplatelet therapy (DAPT, aspirin plus P2Y12 inhibitor) for 1-3 months, followed by long-term single antiplatelet therapy (SAPT, aspirin or P2Y12 inhibitor). * Patients with bailout stenting will generally receive DAPT for 6 months unless deemed as with high ischemic and/or bleeding risks (see "special consideration" in Drug-eluting stent Arm), and then followed by long-term SAPT.

Drug-coated balloon dominant strategy

Drug-eluting stent DEVICE

* Patients treated with DES will generally receive DAPT for 6 months unless deemed as with high ischemic and/or bleeding risks (see "special consideration" below), and then followed by long-term SAPT. * Special consideration: 1. Patients will take additional assessment (both DAPT score and PRECISE-DAPT score) to determine their personalized duration of DAPT. 2. The duration of DAPT is extended to 12 months for patients diagnosed as acute coronary syndrome within 12 months. 3. If anticoagulation is indicated, patient will receive a short-term triple antithrombotic therapy (generally 1 to 4 weeks), followed by a variable length of dual antithrombotic therapy (oral anticoagulation (OAC) plus a single antiplatelet agent, preferably clopidogrel) and subsequent long-term OAC mono-therapy. The duration of dual antithrombotic therapy is determined by bleeding risks (HAS-BLED score) according to current guidelines.

Drug-eluting stent only strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \< 0.8.
• 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

You may not qualify if:

• 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
• Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology
• Identification of a coronary thrombus by angiography
• Patients who have received percutaneous coronary intervention (including stent implantation, plain old balloon angioplasty, and DCB angioplasty) within 12 months before the index procedure.
• Currently recommended indications for DCB: in-stent restenosis, bifurcation lesions requiring concomitant intervention of the major vessel and its adjacent side branch (e.g., lesions requiring dual stent implantation, kissing balloon technique, etc.)
• Lesions with any of the following anatomical characteristics presumably not suitable for DCB treatment:

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences

Beijing, 100037, China

RECRUITING

MeSH Terms

Interventions

Drug-Eluting Stents

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Yongjian Wu, MD,PhD

CONTACT

13701387189; yongjianwu_nccd@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Coronary Heart Disease Center

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 16, 2023
• Study Start: October 15, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)