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 | Recruiting

• 1 other identifier: GE IDE no. BA00219
• Study Type: interventional
• Target: 376
• Locations: 2 countries
• Sites: 5

Brief 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

Coronary Artery Disease; Restenoses, Coronary

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of major adverse cardiac event (MACE)

  Composite endpoint of major adverse cardiac event (MACE) * all-cause death * myocardial infarction * target lesion revascularization (TLR)

  24 months of clinical follow-up after randomization

Secondary Outcomes (4)

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

  24 months of clinical follow-up after randomization

• Individual endpoints of the composite endpoints

  24 months of clinical follow-up after randomization

• Stent thrombosis according to the ARC criteria

  24 months of clinical follow-up after randomization

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

  24 months of clinical follow-up after randomization

Study Arms (2)

homogenous

OTHER

Stratification - homogenous pattern

Device: Drug eluting stent (DES); Device: Drug coated ballloon (DCB)

heterogenous

OTHER

Stratification - homogenous pattern

Device: Drug eluting stent (DES); Device: Drug coated ballloon (DCB)

Interventions

Drug eluting stent (DES) DEVICE

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

heterogenous; homogenous

Drug coated ballloon (DCB) DEVICE

DCB angioplasty with any commercially available drug-coated balloon

heterogenous; homogenous

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• EvidentIQ Germany GmbH: collaborator
• Abbott: collaborator
• Technical University of Munich: collaborator

Study Sites (5)

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, D-60596, Germany

RECRUITING

Elisabeth-Krankenhaus Essen GmbH

Essen, 45138, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, D-20246, Germany

RECRUITING

Deutsches Herzzentrum München

Munich, 80636, Germany

RECRUITING

Hospital Universitario de La Princesa Madrid

Madrid, Madrid, 28006, Spain

RECRUITING

Related Publications (1)

• Simonetti F, Voll F, Alfonso F, Grasser C, Janisch M, Joner M, Kessler T, Kuna C, Leistner DM, Lenz T, Presch A, Rheude T, Sager H, Schunkert H, Starnecker F, Wiebe J, Kastrati A, Cassese S, Xhepa E. 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: Rationale and Design of the ISAR-DESIRE 5 Trial. J Cardiovasc Transl Res. 2025 Oct;18(5):1176-1184. doi: 10.1007/s12265-025-10650-x. Epub 2025 Jun 30.

  PMID: 40588613 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Stenosis

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Felix Voll, MD

CONTACT

+49 89 1218 2749; voll@dhm.mhn.de

Salvatore Cassese, MD, PHD

CONTACT

+49 89 1218 2764; cassese@dhm.mhn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 19, 2022
• Study Start: September 28, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); ES (1)