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

NCT07363161 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2184

Last updated 2026-01-23

No results posted yet for this study

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)

Interventions

DEVICE

PCI

PCI with SeQuent® SCB

DEVICE

PCI

PCI with DES

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-06-30
Completion
2031-03-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07363161 on ClinicalTrials.gov