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Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5

NCT05544864 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2025-01-06

No results posted yet for this study

Summary

The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.

Conditions

Interventions

DEVICE

Drug eluting stent (DES)

DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)

DEVICE

Drug coated ballloon (DCB)

DCB angioplasty with any commercially available drug-coated balloon

Sponsors & Collaborators

  • EvidentIQ Germany GmbH

    collaborator UNKNOWN

  • Abbott

    collaborator INDUSTRY

  • Technical University of Munich

    collaborator OTHER

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-28
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05544864 on ClinicalTrials.gov