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

NCT07363161 | Not Yet Recruiting

• 1 other identifier: AAG-G-H-24094
• Study Type: interventional
• Target: 2,184
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Coronary Artery Disease (CAD)

Keywords

CAD; SCB; SeQuent® SCB

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (102)

• 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)

  at 3 months

• DOCE

  at 12 months

• DOCE

  at 24 months

Study Arms (2)

SeQuent® SCB-based strategy

ACTIVE COMPARATOR

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

DES-based strategy

ACTIVE COMPARATOR

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

Interventions

PCI DEVICE

PCI with SeQuent® SCB

SeQuent® SCB-based strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• High anatomical risk lesions requiring treatment as follows:
• Multivessel treatment (two or three vessels)
• True bifurcation with side branch involvement
• Long lesions (≥36 mm)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Sites (1)

Stadtspital Zürich, Klinik für Kardiologie

Zurich, 8063, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Jiani Wang, Dr.

CONTACT

+4915146206456; Jiani.Wang@bbraun.com

Franziska Greifzu, Dr.

CONTACT

+4930568207371; Franziska.Greifzu@bbraun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2031
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)