NCT07363161 - BASel Kosten-Effektivitäts-Trial: Drug-coated BALLoon (DCB) vs. Drug-eluting Stent (DES) Strategy in High-risk Patients With Coronary Artery Disease (CAD) | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject must be 18 years of age or older * Subject can understand risks, benefits, and treatment alternatives of receiving DCB treatment or DES and provide written informed consent before any study-related procedure * Subject should have a documented angina pectoris or silent ischemia as assessed by non-invasive testing, or functional invasive assessment, or equivalent (dyspnea, arrhythmia, ≥75% diameter stenosis without stress test at staged procedure), or unstable angina, hemodynamically stable NSTEMI and STEMI more than 48 hours after primary PCI and without residual thrombotic material * Subject must be affiliated with a social security system, where applicable Subject must have at least one of the high clinical or anatomical risk features: High clinical risk, defined as: * DM on treatment (insulin or oral antidiabetic agents), or * At least 75 years of age, or * CKD (eGFR \<60 mL/min/1.73 m2), or * Treated for ACS (unstable angina, hemodynamically stable NSTEMI, hemodynamically stable STEMI more than 48 hours after uneventful primary PCI and without residual thrombotic material), or * High bleeding risk (defined by Academic Research Consortium criteria - ARC HBR) OR High anatomical risk lesions requiring treatment as follows: * Multivessel treatment (two or three vessels) * True bifurcation with side branch involvement * Long lesions (≥36 mm) * Lesion likely requiring calcium modification In the case of multivessel (MV) disease, multiple vessels can be treated provided that all lesions are amenable to treatment with either DCB or DES and vessel size at the site of the lesion is \>2.0 mm by visual assessment. The trial does not restrict the number of target lesions. However, the operator should determine that all target lesions intended to be treated must be suitable for treatment with either DES or DCB. For patients randomized to the DCB arm, the likelihood of requiring provisional stenting must be assessed as less than 30% for each lesion requiring treatment. Exclusion Criteria: * Primary PCI (acute STEMI patients) * Cardiogenic shock * Subject enrolled in an active interventional trial * Subject not able or unlikely to comply with the planned follow-ups * Subject who is pregnant, nursing or planning to become pregnant during the study * Subject not able to give informed consent * Subject under judicial protection, guardianship or curatorship or patient deprived of their liberty by judicial or administrative decision (where applicable) * Subject with a life expectancy \<12 months * Subjects with known allergies to antiplatelet agents (e.g., acetylsalicylic acid, P2Y12 inhibitors), anticoagulants (e.g., heparin, direct thrombin inhibitors), iodinated contrast media, or mTOR inhibitors (e.g., sirolimus and related compounds) * Angiographic exclusion criteria: 1. aorto-ostial lesions, 2. coronary bypass grafts requiring intervention, 3. chronic total occlusion requiring intervention 4. Previous PCI at any time of a vessel intended to be treated (Instent-restenosis lesions excluded) 5. Previous PCI within 30 days, except for recent STEMI, \>48 hours after uneventful primary PCI and without residual thrombotic material on coronary angiography

Outcomes

Primary Outcomes

Composite of Target Vessel Failure (TVF) and bleeding according to Bleeding Academic Research Consortium (BARC) Types 3-5

Time frame: at 12 months (after intervention)

Composite of TVF and bleeding BARC 3-5

Time frame: at 36 months

Secondary Outcomes

Composite of TVF and bleeding BARC 3-5

Time frame: at 3 months

Composite of TVF and bleeding BARC 3-5

Time frame: at 24 months

Device-oriented Composite Endpoint (DOCE)

a composite of cardiovascular death (CV death), device failure-related myocardial infarction (MI), and clinically indicated Target Lesion Revascularization (ci-TLR)

Time frame: at 3 months

DOCE

Time frame: at 12 months

DOCE

Time frame: at 24 months

DOCE

Time frame: at 36 months

TVF

Time frame: at 3 months

TVF

Time frame: at 12 months

TVF

Time frame: at 24 months

TVF

Time frame: at 36 months

Patient-oriented Composite endpoint (POCE)

a composite of any death, any MI, any stroke, and any revascularization

Time frame: at 3 months

POCE

Time frame: at 12 months

POCE

Time frame: at 24 months

POCE

Time frame: at 36 months

Any death

Time frame: at 3 months

Any death

Time frame: at 12 months

Any death

Time frame: at 24 months

Any death

Time frame: at 36 months

CV death

Time frame: at 3 months

CV death

Time frame: at 12 months

CV death

Time frame: at 24 months

CV death

Time frame: at 36 months

Cardiac death

Time frame: at 3 months

Cardiac death

Time frame: at 12 months

Cardiac death

Time frame: at 24 months

Cardiac death

Time frame: at 36 months

Any MI

Time frame: at 3 months

Any MI

Time frame: at 12 months

Any MI

Time frame: at 24 months

Any MI

Time frame: at 36 months

Target Vessel-Related MI

Time frame: at 3 months

Target Vessel-Related MI

Time frame: at 12 months

Target Vessel-Related MI

Time frame: at 24 months

Target Vessel-Related MI

Time frame: at 36 months

Peri-procedural MI

as defined by Drug Coated Balloon Academic Research Consortium (DCB ARC)

Time frame: at 3 months

Peri-procedural MI

Time frame: at 12 months

Peri-procedural MI

Time frame: at 24 months

Peri-procedural MI

Time frame: at 36 months

Spontaneous MI

according to 4th Universal Definition of MI

Time frame: at 3 months

Spontaneous MI

Time frame: at 12 months

Spontaneous MI

Time frame: 24 months

Spontaneous MI

Time frame: at 36 months

BARC type ≥2 bleeding

Time frame: at 3 months

BARC type ≥2 bleeding

Time frame: at 12 months

BARC type ≥2 bleeding

Time frame: at 24 months

BARC type ≥2 bleeding

Time frame: at 36 months

BARC 3-5 bleeding

Time frame: at 3 months

BARC 3-5 bleeding

Time frame: at 12 months

BARC 3-5 bleeding

Time frame: at 24 months

BARC 3-5 bleeding

Time frame: at 36 months

Definite stent/lesion thrombosis

Time frame: at 3 months

Definite stent/lesion thrombosis

Time frame: at 12 months

Definite stent/lesion thrombosis

Time frame: at 24 months

Definite stent/lesion thrombosis

Time frame: at 36 months

Stroke

ischemic and hemorrhagic

Time frame: at 3 months

Stroke

Time frame: at 12 months

Stroke

Time frame: at 24 months

Stroke

Time frame: at 36 months

Any TLR

Time frame: at 3 months

Any TLR

Time frame: at 12 months

Any TLR

Time frame: at 24 months

Any TLR

Time frame: at 36 months

ci-TLR

Time frame: at 3 months

ci-TLR

Time frame: at 12 months

ci-TLR

Time frame: at 24 months

ci-TLR

Time frame: at 36 months

Any TVR

Time frame: at 3 months

Any TVR

Time frame: at 12 months

Any TVR

Time frame: at 24 months

Any TVR

Time frame: at 36 months

ci-TVR

Time frame: at 3 months

ci-TVR

Time frame: at 12 months

ci-TVR

Time frame: at 24 months

ci-TVR

Time frame: at 36 months

Dual Antiplatelet Therapy (DAPT) burden

total duration of DAPT and/or Single Antiplatelet Therapy (SAPT)

Time frame: at 3 months

DAPT burden

Time frame: at 12 months

DAPT burden

Time frame: at 24 months

DAPT burden

Time frame: at 36 months

Hospitalization related to study endpoints

Time frame: at 3 months

Hospitalization related to study endpoints

Time frame: at 12 months

Hospitalization related to study endpoints

Time frame: at 24 months

Hospitalization related to study endpoints

Time frame: at 36 months

Procedure success

defined as Device success and freedom from in-hospital cardiovascular death, TLR, peri-procedural MI, any stroke, and BARC 3 or 5 bleeding

Time frame: at 3 months

Procedure success

Time frame: at 12 months

Procedure success

Time frame: at 24 months

Procedure success

Time frame: at 36 months

Device success (DCB)

defined as successful delivery in time and inflation within 30-60 s of the allocated DCB device at the intended target lesion during an attempt with a DCB not previously used (first use); successful withdrawal of the device system; attainment of a final in-segment or in-lesion residual stenosis of \<30% (except in the side branch ostium in nonleft main bifurcation lesions \<70%) by visual estimate

Time frame: at 3 months

Device success (DCB)

Time frame: at 12 months

Device success (DCB)

Time frame: at 24 months

Device success (DCB)

Time frame: at 36 months

Device success (DES)

defined as successful delivery, balloon expansion, and deployment of the first assigned DES at the intended target lesion; successful withdrawal of the device delivery system; attainment of a final in-stent residual stenosis of \<20% by visual estimate

Time frame: at 3 months

Device success (DES)

Time frame: at 12 months

Device success (DES)

Time frame: at 24 months

Device success (DES)

Time frame: at 36 months

Metal burden

by assessing the total stent length

Time frame: at 3 months

Metal burden

Time frame: at 12 months

Metal burden

Time frame: at 24 months

Metal burden

Time frame: at 36 months

In-segment net gain

Main angiographic endpoint after completion of the 12-month follow-up

Time frame: assessed between 12 and 13 months

Cost-effectiveness of DCB-based vs. DES-based strategy

Time frame: at 12 months

Cost-effectiveness of DCB-based vs. DES-based strategy

Time frame: at 24 months

Cost-effectiveness of DCB-based vs. DES-based strategy

Time frame: at 36 months

BASel Kosten-Effektivitäts-Trial: Drug-coated BALLoon (DCB) vs. Drug-eluting Stent (DES) Strategy in High-risk Patients With Coronary Artery Disease (CAD)

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts