Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05544864

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Frankfurt, Frankfurt am Main, Hesse, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with ischemic symptoms and/or evidence of myocardial ischemia
  • Presence of ≥ 50% restenosis after prior implantation of drug-eluting stents in native coronary vessels.
  • Availability of an OCT-pullback of the target lesion
  • Written informed consent by the patient for participation in the study.
  • Age ≥ 18 years

Exclusion criteria

  • Cardiogenic shock
  • Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
  • Target lesion located in left main trunk or bypass graft.
  • Additional coronary intervention planned within 30 days of the procedure.
  • Non-successful treatment of other lesion(s) during the same procedure
  • Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
  • Contraindications to any components of the investigational devices or dual antiplatelet therapy
  • Pregnancy (present, suspected or planned) or positive pregnancy test.
  • Previous enrollment in this trial or participation in any other study at the time of enrollment.
  • Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance.
  • Patient's inability to fully comply with the study protocol

Treatment and study plan

Drug Eluting Stent (DES)

Device

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

Drug coated ballloon (DCB)

Device

DCB angioplasty with any commercially available drug-coated balloon

Primary outcomes

  1. Composite endpoint of major adverse cardiac event (MACE)

    Time frame: 24 months of clinical follow-up after randomization

    Composite endpoint of major adverse cardiac event (MACE)

    • all-cause death
    • myocardial infarction
    • target lesion revascularization (TLR)

Secondary outcomes

  1. Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR

    Time frame: 24 months of clinical follow-up after randomization

  2. Individual endpoints of the composite endpoints

    Time frame: 24 months of clinical follow-up after randomization

    • all-cause death
    • myocardial infarction
    • target lesion revascularization (TLR)
  3. Stent thrombosis according to the ARC criteria

    Time frame: 24 months of clinical follow-up after randomization

  4. Safety endpoint: a composite endpoint of all-cause death and myocardial infarction

    Time frame: 24 months of clinical follow-up after randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Felix Voll, MD

CONTACT

[email protected]

+49 89 1218 2749

Salvatore Cassese, MD, PHD

CONTACT

[email protected]

+49 89 1218 2764

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • Abbott
  • EvidentIQ Germany GmbH
  • Technical University of Munich

Registry information

Acronym: ISAR-DESIRE5

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2022
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.