Status:
UNKNOWN
STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Drug-coated Balloon
Drug-eluting Stent
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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:
- long lesion with length \>= 40mm.
- 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
- 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.
- lesions in left main coronary artery
- 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:
- 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.
- Severe renal insufficiency with estimated glomerular filtration rate \< 30 ml/min/1.73m2.
- Malignant tumor.
- A life expectancy of less than 1 year.
- Unsuitable for coronary intervention or long-term antithrombotic therapy
- Myocardial bridging located at target lesions.
- 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.
- Open surgery is planned within six months after discharge.
- Intolerable to double (aspirin plus P2Y12 inhibitor) or single (aspirin or P2Y12 inhibitor) antiplatelet therapy.
- History of intracranial hemorrhage.
- 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.
Key Trial Info
Start Date :
October 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
2700 Patients enrolled
Trial Details
Trial ID
NCT06084000
Start Date
October 15 2023
End Date
December 30 2025
Last Update
October 17 2023
Active Locations (1)
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1
Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
Beijing, China, 100037