AzTrials
AzTrials

Coronary Artery Disease (CAD)BASKET BALLNCT07363161

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

A study testing PCI in people with Coronary Artery Disease (CAD), run by B. Braun Melsungen AG at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease (CAD)
What is being tested?
PCI
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,184 participants
Where
3 sitesin 2 countries
Study dates
17 Jun 2026to Mar 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 19Show fewer
  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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:
  • 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

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Jiani Wang, Dr. contact

+49 151 46206456

Jiani.Wang@bbraun.com

Franziska Greifzu, Dr. contact

+49 30 568207371

Franziska.Greifzu@bbraun.com

3 sites in 2 countries

Switzerland2 sites, 2 recruiting

  • University Hospital Basel

    Basel, 4031

    Gregor Leibundgut, Prof. Dr. med., +41 61 2654444, Gregor.Leibundgut@usb.ch

    Gregor Leibundgut, Prof. Dr. med.

    Not yet recruiting

  • Stadtspital Zürich - Klinik für Kardiologie

    Zurich, 8063

    Raban Jeger, Prof. Dr. med., +41 44 4163350, Raban.Jeger@stadtspital.ch

    Raban Jeger, Prof. Dr. med.

    Recruiting

Other trials in Switzerland

Germany1 site, 1 recruiting

  • Universität des Saarlandes - Klinik für Innere Medizin III

    Homburg, 66421

    Bruno Scheller-Clever, Univ. Prof. Dr. med., +49 6841 1615927, Bruno.Scheller@uks.eu

    Bruno Scheller-Clever, Univ. Prof. Dr. med.

    Not yet recruiting

Other trials in Germany

About this study

Official title: 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:

Read more
  • 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.

Being tested
PCI
Keywords
CAD, SCB, SeQuent® SCB
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCIDevice

    PCI with SeQuent® SCB

  • PCIDevice

    PCI with DES

Study groups in NCT07363161
Study groupRoleWhat they receive
SeQuent® SCB-based strategyActive comparatorall 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.
Receives: Device: PCI
DES-based strategyActive comparatorall 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.
Receives: Device: PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: at 12 months (after intervention)

  2. Composite of TVF and bleeding BARC 3-5

    Measured: at 36 months

Secondary outcomes (102)

  1. Composite of TVF and bleeding BARC 3-5

    Measured: at 3 months

  2. Composite of TVF and bleeding BARC 3-5

    Measured: at 24 months

  3. 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)

    Measured: at 3 months

  4. DOCE

    Measured: at 12 months

  5. DOCE

    Measured: at 24 months

  6. DOCE

    Measured: at 36 months

  7. TVF

    Measured: at 3 months

  8. TVF

    Measured: at 12 months

  9. TVF

    Measured: at 24 months

  10. TVF

    Measured: at 36 months

  11. Patient-oriented Composite endpoint (POCE)

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

    Measured: at 3 months

  12. POCE

    Measured: at 12 months

  13. POCE

    Measured: at 24 months

  14. POCE

    Measured: at 36 months

  15. Any death

    Measured: at 3 months

  16. Any death

    Measured: at 12 months

  17. Any death

    Measured: at 24 months

  18. Any death

    Measured: at 36 months

  19. CV death

    Measured: at 3 months

  20. CV death

    Measured: at 12 months

  21. CV death

    Measured: at 24 months

  22. CV death

    Measured: at 36 months

  23. Cardiac death

    Measured: at 3 months

  24. Cardiac death

    Measured: at 12 months

  25. Cardiac death

    Measured: at 24 months

  26. Cardiac death

    Measured: at 36 months

  27. Any MI

    Measured: at 3 months

  28. Any MI

    Measured: at 12 months

  29. Any MI

    Measured: at 24 months

  30. Any MI

    Measured: at 36 months

  31. Target Vessel-Related MI

    Measured: at 3 months

  32. Target Vessel-Related MI

    Measured: at 12 months

  33. Target Vessel-Related MI

    Measured: at 24 months

  34. Target Vessel-Related MI

    Measured: at 36 months

  35. Peri-procedural MI

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

    Measured: at 3 months

  36. Peri-procedural MI

    Measured: at 12 months

  37. Peri-procedural MI

    Measured: at 24 months

  38. Peri-procedural MI

    Measured: at 36 months

  39. Spontaneous MI

    according to 4th Universal Definition of MI

    Measured: at 3 months

  40. Spontaneous MI

    Measured: at 12 months

  41. Spontaneous MI

    Measured: 24 months

  42. Spontaneous MI

    Measured: at 36 months

  43. BARC type ≥2 bleeding

    Measured: at 3 months

  44. BARC type ≥2 bleeding

    Measured: at 12 months

  45. BARC type ≥2 bleeding

    Measured: at 24 months

  46. BARC type ≥2 bleeding

    Measured: at 36 months

  47. BARC 3-5 bleeding

    Measured: at 3 months

  48. BARC 3-5 bleeding

    Measured: at 12 months

  49. BARC 3-5 bleeding

    Measured: at 24 months

  50. BARC 3-5 bleeding

    Measured: at 36 months

  51. Definite stent/lesion thrombosis

    Measured: at 3 months

  52. Definite stent/lesion thrombosis

    Measured: at 12 months

  53. Definite stent/lesion thrombosis

    Measured: at 24 months

  54. Definite stent/lesion thrombosis

    Measured: at 36 months

  55. Stroke

    ischemic and hemorrhagic

    Measured: at 3 months

  56. Stroke

    Measured: at 12 months

  57. Stroke

    Measured: at 24 months

  58. Stroke

    Measured: at 36 months

  59. Any TLR

    Measured: at 3 months

  60. Any TLR

    Measured: at 12 months

  61. Any TLR

    Measured: at 24 months

  62. Any TLR

    Measured: at 36 months

  63. ci-TLR

    Measured: at 3 months

  64. ci-TLR

    Measured: at 12 months

  65. ci-TLR

    Measured: at 24 months

  66. ci-TLR

    Measured: at 36 months

  67. Any TVR

    Measured: at 3 months

  68. Any TVR

    Measured: at 12 months

  69. Any TVR

    Measured: at 24 months

  70. Any TVR

    Measured: at 36 months

  71. ci-TVR

    Measured: at 3 months

  72. ci-TVR

    Measured: at 12 months

  73. ci-TVR

    Measured: at 24 months

  74. ci-TVR

    Measured: at 36 months

  75. Dual Antiplatelet Therapy (DAPT) burden

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

    Measured: at 3 months

  76. DAPT burden

    Measured: at 12 months

  77. DAPT burden

    Measured: at 24 months

  78. DAPT burden

    Measured: at 36 months

  79. Hospitalization related to study endpoints

    Measured: at 3 months

  80. Hospitalization related to study endpoints

    Measured: at 12 months

  81. Hospitalization related to study endpoints

    Measured: at 24 months

  82. Hospitalization related to study endpoints

    Measured: at 36 months

  83. 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

    Measured: at 3 months

  84. Procedure success

    Measured: at 12 months

  85. Procedure success

    Measured: at 24 months

  86. Procedure success

    Measured: at 36 months

  87. 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

    Measured: at 3 months

  88. Device success (DCB)

    Measured: at 12 months

  89. Device success (DCB)

    Measured: at 24 months

  90. Device success (DCB)

    Measured: at 36 months

  91. 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

    Measured: at 3 months

  92. Device success (DES)

    Measured: at 12 months

  93. Device success (DES)

    Measured: at 24 months

  94. Device success (DES)

    Measured: at 36 months

  95. Metal burden

    by assessing the total stent length

    Measured: at 3 months

  96. Metal burden

    Measured: at 12 months

  97. Metal burden

    Measured: at 24 months

  98. Metal burden

    Measured: at 36 months

  99. In-segment net gain

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

    Measured: assessed between 12 and 13 months

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

    Measured: at 12 months

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

    Measured: at 24 months

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

    Measured: at 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start17 Jun 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionMar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,184 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07363161
Sponsor's protocol ID
AAG-G-H-24094
Acronym
BASKET BALL
Status last verified
Jul 2026
First submitted
15 Jan 2026
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PCI in people with Coronary Artery Disease (CAD), run by B. Braun Melsungen AG at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jiani Wang, Dr. (+49 151 46206456, Jiani.Wang@bbraun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07363161.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in