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

NCT ID: NCT06084000

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2025-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug-coated balloon dominant strategy

• 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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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-eluting stent only strategy

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

Group Type: ACTIVE_COMPARATOR

Drug-eluting stent

Intervention Type: 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.

Interventions

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

• 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.

Intervention Type: DEVICE

Drug-eluting stent

• 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.

Intervention Type: DEVICE

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:

1. visual angiographic stenosis with severity >= 70%.

2. 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

Exclusion Criteria

• History of acute coronary syndrome within the last 6 months.

• Acute coronary syndrome is defined as 1 of following diagnosis:

1. Unstable Angina Pectoris (UAP)

2. ST-Elevated Myocardial Infarction (STEMI)

3. 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:

1. Symptoms of myocardial ischemia

2. New ischemic ECG changes

3. Development of pathological Q waves

4. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology

5. Identification of a coronary thrombus by angiography

• All types of MI (type 1 to 5 MI) defined by "the Fourth Universal Definition of Myocardial Infarction (2018)", which occurred within the last 6 months from inclusion phase would be excluded from this study.
• 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:

1. long lesion with length >= 40mm.

2. severely calcified, moderate or severe tortuous, or severe angulated vessels, especially when vessel recoil seems possible.

• Moderate tortuosity: 2 bends >75° or 1 bend >90° to reach the target lesion.
• Severe tortuosity: 2 bends >90° or 3 bends >75° to reach the target lesion.
• Severe angulation: angulated segment > 90°
• Severe calcification: radiopacities noted without cardiac motion before contrast injection generally compromising both sides of the arterial lumen

3. Chronic total occlusion

• Definition: A lesion of a coronary artery becomes completely blocked for a duration of greater than or equal to 3 months based on angiographic evidence.

4. lesions in left main coronary artery

5. lesions in venous or arterial graft

• Chronic heart failure with left ventricular ejection fraction < 35% after 6 months of Guideline-Directed Medical Treatment (GDMT)
• Acute heart failure, hemodynamic instability, or cardiogenic shock

• Acute heart failure is defined as a rapid onset of new or worsening signs and symptoms of heart failure.
• Non-cardiac Comorbidities:

1. Severe liver insufficiency defined as 1 of the following:

• alanine transaminase or aspartate transaminase more than 5-fold of upper reference limit.
• Child-Pugh grade B or C.

2. Severe renal insufficiency with estimated glomerular filtration rate < 30 ml/min/1.73m2.

3. Malignant tumor.

4. A life expectancy of less than 1 year.

• Unsuitable for coronary intervention or long-term antithrombotic therapy

1. Myocardial bridging located at target lesions.

2. Major bleeding (BARC type 2 to 5) or active pathological bleeding (including gastrointestinal or genitourinary bleeding) within 3 months,or major surgery within 2 months.

3. Open surgery is planned within six months after discharge.

4. Intolerable to double (aspirin plus P2Y12 inhibitor) or single (aspirin or P2Y12 inhibitor) antiplatelet therapy.

5. History of intracranial hemorrhage.

6. Pregnant women, lactating women, and women of childbearing potential.

• History of artificial valve replacement.
• History of participating in any other clinical studies or trials within 12 months before the index procedure.
• Participants deemed unsuitable to be enrolled by investigators, such as conditions that may result in protocol nonadherence.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yongjian Wu, MD, PhD

Director of Coronary Heart Disease Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongjian Wu, MD,PhD

Role: CONTACT

yongjianwu_nccd@163.com

13701387189

Facility Contacts

Yongjian Wu, PhD

Role: primary

+86 13701387189

Other Identifiers

2023-I2M-1-002

Identifier Type: -

Identifier Source: org_study_id