Clinical trial NCT06084000: STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial
Official title: STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug-coated Balloon
Drug-eluting Stent
De Novo Stenosis
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-10-16
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of a composite of cardiac death, target-vessel myocardial infarction and clinically indicated target vessel revascularization
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 30 days
measure: Incidence of cardiac death
timeFrame: 12 months
measure: Incidence of target-vessel myocardial infarction
timeFrame: 12 months
measure: Incidence of clinically indicated target vessel revascularization
timeFrame: 12 months
measure: Incidence of a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and re-hospitalization
timeFrame: 12 months
measure: Incidence of major bleeding (Bleeding Academic Research Consortium [BARC] definition, type 2 to 5)
timeFrame: 12 months
measure: Incidence of net clinical benefit (a composite of cardiac death, target-vessel myocardial infarction, clinically indicated target vessel revascularization and major bleeding)
timeFrame: 12 months
measure: Score of Seattle Angina Questionnaire (SAQ)
timeFrame: 1, 6 and 12 months
measure: Score of EuroQol Five Dimensions-5L (EQ-5D-5L)
timeFrame: 1, 6 and 12 months
measure: Quality-adjusted life-years (QALYs)
timeFrame: 12 months
measure: Total costs
timeFrame: 12 months
measure: Incremental cost-effectiveness ratios (ICER)
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
Study officials:
References: