Drug-coated Balloon (DCB) vs. Drug-eluting Stent (DES) in High-risk Patients With Coronary Artery Disease (CAD) (BASKET BALL)

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

The main objective of this randomized, multicenter, international, open-label clinical trial is to demonstrate that, in the context of percutaneous coronary intervention for complex coronary artery disease, a SeQuent® SCB interventional strategy is non-inferior to a new-generation

DES strategy in terms of a 12- and 36-month composite of Target Vessel Failure (TVF), that includes:

• cardiovascular death (CV death),
• target vessel related MI (TV-MI),
• clinically indicated target vessel revascularization (ci-TVR),
• bleeding according to Bleeding Academic Research Consortium (BARC) Types 3-5.

Eligible subjects will be assigned in a 1:1 ratio to receive treatment of all lesions with either the SeQuent® SCB-based strategy or a DES-based strategy. The randomization will be performed prior to the index procedure once signed informed consent has been obtained and all eligibility criteria have been confirmed.

All Subjects will be followed for clinical outcomes at 3 months, 1, 2, and 3 years. A subset of 138 randomized patients will undergo control angiography after one-year clinical follow-up (+1 month). An independent core laboratory will analyze all baseline angiograms.

If, at 36 months, the non-inferiority of the SeQuent® SCB strategy compared to the DES strategy is achieved, superiority in terms of TVF and BARC Type 3-5 bleeding will be tested.

An optional extension of follow-up to 6 years may be implemented based on interim results and the joint decision of the Steering Committee and the Sponsor. Details regarding this optional extension are provided in the Clinical Investigation Plan.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease (CAD)
• Intervention / Treatment: Device: PCI; Device: PCI

• Study Type: Interventional
• Enrollment (Estimated): 2184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiani Wang, Dr.; Phone Number: +4915146206456; Email: Jiani.Wang@bbraun.com
• Study Contact Backup: Name: Franziska Greifzu, Dr.; Phone Number: +4930568207371; Email: Franziska.Greifzu@bbraun.com

Study Locations

• Switzerland
  • Zurich, Switzerland, 8063
    • Stadtspital Zürich, Klinik für Kardiologie
    • Contact: Raban Jeger, Prof. Dr. med.; Phone Number: +41444163350; Email: Raban.Jeger@stadtspital.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SeQuent® SCB-based strategy; all target lesions should be treated with the SeQuent® SCB after adequate lesion preparation. If the angiographic result is unacceptable following lesion preparation or after DCB treatment (e.g., flow-limiting dissection or residual stenosis >30%), additional therapeutic steps should be considered. For non-left main bifurcation lesions, if the side branch requires treatment, it should also be treated with the SeQuent® SCB after adequate lesion preparation. If an unacceptable angiographic result, defined as >70% residual stenosis or major recoil at the side branch ostium, is obtained, or if there is an imminent risk of vessel compromise, further therapeutic steps are required. Those steps may include optimized lesion preparation to avoid DES implantation; however, DES may be implanted if all other attempts fail.	Device: PCI; PCI with SeQuent® SCB; Device: PCI; PCI with DES
Active Comparator: DES-based strategy; all target lesions should be treated with DES. The use of DCB in the DES arm is strongly discouraged. If DES delivery is not feasible due to anatomical or other reasons, the operator may consider alternative treatments, such as more deliverable DES or plain old balloon angioplasty (POBA), while keeping the patients in the DES group. In case of bifurcation treatment, both DES and POBA are allowed. Any use of DCB in the DES arm shall be justified.	Device: PCI; PCI with SeQuent® SCB; Device: PCI; PCI with DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of Target Vessel Failure (TVF) and bleeding according to Bleeding Academic Research Consortium (BARC) Types 3-5	at 12 months (after intervention)
Composite of TVF and bleeding BARC 3-5	at 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of TVF and bleeding BARC 3-5		at 3 months
Composite of TVF and bleeding BARC 3-5		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)	at 3 months
DOCE		at 12 months
DOCE		at 24 months
DOCE		at 36 months
TVF		at 3 months
TVF		at 12 months
TVF		at 24 months
TVF		at 36 months
Patient-oriented Composite endpoint (POCE)	a composite of any death, any MI, any stroke, and any revascularization	at 3 months
POCE		at 12 months
POCE		at 24 months
POCE		at 36 months
Any death		at 3 months
Any death		at 12 months
Any death		at 24 months
Any death		at 36 months
CV death		at 3 months
CV death		at 12 months
CV death		at 24 months
CV death		at 36 months
Cardiac death		at 3 months
Cardiac death		at 12 months
Cardiac death		at 24 months
Cardiac death		at 36 months
Any MI		at 3 months
Any MI		at 12 months
Any MI		at 24 months
Any MI		at 36 months
Target Vessel-Related MI		at 3 months
Target Vessel-Related MI		at 12 months
Target Vessel-Related MI		at 24 months
Target Vessel-Related MI		at 36 months
Peri-procedural MI	as defined by Drug Coated Balloon Academic Research Consortium (DCB ARC)	at 3 months
Peri-procedural MI		at 12 months
Peri-procedural MI		at 24 months
Peri-procedural MI		at 36 months
Spontaneous MI	according to 4th Universal Definition of MI	at 3 months
Spontaneous MI		at 12 months
Spontaneous MI		24 months
Spontaneous MI		at 36 months
BARC type ≥2 bleeding		at 3 months
BARC type ≥2 bleeding		at 12 months
BARC type ≥2 bleeding		at 24 months
BARC type ≥2 bleeding		at 36 months
BARC 3-5 bleeding		at 3 months
BARC 3-5 bleeding		at 12 months
BARC 3-5 bleeding		at 24 months
BARC 3-5 bleeding		at 36 months
Definite stent/lesion thrombosis		at 3 months
Definite stent/lesion thrombosis		at 12 months
Definite stent/lesion thrombosis		at 24 months
Definite stent/lesion thrombosis		at 36 months
Stroke	ischemic and hemorrhagic	at 3 months
Stroke		at 12 months
Stroke		at 24 months
Stroke		at 36 months
Any TLR		at 3 months
Any TLR		at 12 months
Any TLR		at 24 months
Any TLR		at 36 months
ci-TLR		at 3 months
ci-TLR		at 12 months
ci-TLR		at 24 months
ci-TLR		at 36 months
Any TVR		at 3 months
Any TVR		at 12 months
Any TVR		at 24 months
Any TVR		at 36 months
ci-TVR		at 3 months
ci-TVR		at 12 months
ci-TVR		at 24 months
ci-TVR		at 36 months
Dual Antiplatelet Therapy (DAPT) burden	total duration of DAPT and/or Single Antiplatelet Therapy (SAPT)	at 3 months
DAPT burden		at 12 months
DAPT burden		at 24 months
DAPT burden		at 36 months
Hospitalization related to study endpoints		at 3 months
Hospitalization related to study endpoints		at 12 months
Hospitalization related to study endpoints		at 24 months
Hospitalization related to study endpoints		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	at 3 months
Procedure success		at 12 months
Procedure success		at 24 months
Procedure success		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	at 3 months
Device success (DCB)		at 12 months
Device success (DCB)		at 24 months
Device success (DCB)		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	at 3 months
Device success (DES)		at 12 months
Device success (DES)		at 24 months
Device success (DES)		at 36 months
Metal burden	by assessing the total stent length	at 3 months
Metal burden		at 12 months
Metal burden		at 24 months
Metal burden		at 36 months
In-segment net gain	Main angiographic endpoint after completion of the 12-month follow-up	assessed between 12 and 13 months
Cost-effectiveness of DCB-based vs. DES-based strategy		at 12 months
Cost-effectiveness of DCB-based vs. DES-based strategy		at 24 months
Cost-effectiveness of DCB-based vs. DES-based strategy		at 36 months

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: CAD; SCB; SeQuent® SCB
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: AAG-G-H-24094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No