Drug-coated balloon versus drug-eluting stent for high-risk coronary artery disease
Compares a drug-coated balloon with a drug-eluting stent in adults with coronary artery disease.
Plain-language title generated from the registry record
Registry title: BASel Kosten-Effektivitäts-Trial: Drug-coated BALLoon (DCB) vs. Drug-eluting Stent (DES) Strategy in High-risk Patients With Coronary Artery Disease (CAD)
Key facts
- Where
- Homburg, GermanySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with coronary artery disease who have a high clinical or anatomical risk and need a stent procedure (PCI). It compares a drug-coated balloon with a drug-eluting stent.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Coronary artery disease with angina or silent ischemia, or recent unstable angina or stable heart attack (NSTEMI, or STEMI more than 48 hours after primary PCI). Needs at least one high-risk feature: diabetes on treatment, age 75 or older, kidney disease (eGFR <60 mL/min/1.73 m2), treated acute coronary syndrome, high bleeding risk, two or three vessels to treat, true bifurcation, long lesion (36 mm or more), or lesion likely needing calcium treatment. Vessel size must be above 2.0 mm.
- Earlier treatment
- No earlier stent procedure (PCI) in the vessel to be treated, and none within 30 days, except after a recent STEMI more than 48 hours after primary PCI with no residual thrombotic material.
Main reasons for not taking part
- Primary PCI for acute STEMI, or cardiogenic shock
- Pregnant, nursing or planning pregnancy
- Life expectancy under 12 months
- Known allergy to blood thinners, contrast dye or sirolimus-type drugs
- Blockage at the vessel opening, bypass graft, or chronic total occlusion needing treatment
Read by machine on 12 November 2026.
Where in Germany
- Universität des Saarlandes - Klinik für Innere Medizin IIIHomburg, GermanyContact: Bruno Scheller-Clever, Univ. Prof. Dr. med.Not yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- B. Braun Melsungen AG
- Trial code
- NCT07363161
- Record updated
- 20 July 2026
- Original description
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-generationRead full original descriptionShow less
BASKET BALL - a Prospective, Multicenter, International, Open-label, Randomized Clinical Trial Comparing the Sirolimus-DCB Strategy vs. DES Strategy in de Novo High-risk Patients
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.
Inclusion: 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: Angiographic exclusion criteria:; aorto-ostial lesions,; coronary bypass grafts requiring intervention,; chronic total occlusion requiring intervention; Previous PCI at any time of a vessel intended to be treated (Instent-restenosis lesions excluded); Previous PCI within 30 days, except for recent STEMI, >48 hours after uneventful primary PCI and without residual thrombotic material on coronary angiography; 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); 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.