MedTrace Logo

Drug-Coated Balloon Coronary Angioplasty Versus Stenting for Treatment of Disease Adjacent to a Chronic Total Occlusion.

NCT04881812 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2023-09-22

No results posted yet for this study

Summary

This is an investigator-initiated, randomized, multi-center, non-inferiority clinical trial. Patients with a Chronic Total Occlusion who are eligible for PCI will be randomized to additional Drug-Coated-Balloon treatment or stenting of adjacent residual disease to the CTO body. The aim of this study is to investigate whether treatment with DCB is non-inferior to complete stenting of the CTO body.

Conditions

  • Chronic Total Occlusion of Coronary Artery

Interventions

DEVICE

Drug-Coated Balloons

Percutaneous coronary intervention of residual disease adjacent to a chronic total occlusion with a paclitaxel drug-coated balloon (minimal stenting strategy).

DEVICE

Drug-Eluting-Stent

Percutaneous coronary intervention of the chronic total occlusion and residual coronary artery disease with an everolimus-eluting platinum chromium coronary stent (complete stenting strategy).

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Paul Knaapen, MD PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2024-03-31
Completion
2025-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT04881812 on ClinicalTrials.gov