Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons

NCT07231835 | Recruiting

• 1 other identifier: 2025.0981
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this registry is to systematically collect and analyze real-world data on all patients undergoing PCI with the Protégé paclitaxel-eluting DCB to evaluate procedural outcomes, long-term efficacy, and safety across various clinical indications. This registry aims to assess the clinical effectiveness of DCB therapy across diverse patient populations, including those with stable coronary artery disease (CAD) and acute coronary syndromes (ACS), as well as various lesion subsets, encompassing (but not limited to) in-stent restenosis (ISR), de novo coronary lesions, small vessel disease, bifurcation and calcified lesions, coronary bypass graft lesions, and patients at high risk of bleeding. Additionally, the study aims to identify predictors of success, complications, and optimal treatment strategies to further refine the use of DCBs.

Conditions

Percutaneous Coronary Intervention (PCI); Drug Coated Balloon; Paclitaxel; CAD - Coronary Artery Disease; ACS (Acute Coronary Syndrome); Stable Coronary Artery Disease (CAD), Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• TLF at 1 year

  Target Lesion Failure (TLF) at 1 year, defined as a composite of: * Cardiovascular death * Target vessel myocardial infarction (TV-MI) * Clinically driven target lesion revascularization (TLR)

  From enrollment to 1 year follow-up

Eligibility Criteria

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

Study Population

Adults (\>18 years) with stable CAD or ACS who have a PCI indication and are treated with the Protégé DCB.

You may qualify if:

• Patients undergoing PCI with the Protégé paclitaxel-eluting DCB
• Age ≥ 18 years
• Presence of a de novo lesion or in-stent restenosis in a native coronary artery or a in a bypass graft and suitable for PCI
• Reference vessel diameter between 2.0 - 4.5 mm
• Patient suitable for dual antiplatelet therapy (DAPT)

You may not qualify if:

• Inability to provide informed consent
• Allergy to paclitaxel

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Inge T Bosch

CONTACT

+31205663884; i.t.bosch@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md phd

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 17, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2034
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

NL (1)