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

National Center for Cardiovascular Diseases

Status

Enrolling

Conditions

Drug-eluting Stent

Drug-coated Balloon

De Novo Stenosis

Treatments

Device: Drug-eluting stent

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06084000

2023-I2M-1-002

Details and patient eligibility

About

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.

Enrollment

2,700 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,700 participants in 2 patient groups

Drug-coated balloon dominant strategy

Experimental group

Description:

* 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.

Treatment:

Drug-eluting stent only strategy

Active Comparator group

Description:

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

Treatment:

Device: Drug-eluting stent