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 (ISAR-DESIRE5)

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Restenoses, Coronary
• Intervention / Treatment: Device: Drug eluting stent (DES); Device: Drug coated ballloon (DCB)

• Study Type: Interventional
• Enrollment (Estimated): 376
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salvatore Cassese, MD, PHD; Phone Number: 2764 +49 89 1218; Email: cassese@dhm.mhn.de
• Study Contact Backup: Name: Felix Voll, MD; Phone Number: 2749 +49 89 1218; Email: voll@dhm.mhn.de

Study Locations

• Germany
  • Hamburg, Germany, D-20246
    • Recruiting
    • Universitätsklinikum Hamburg-Eppendorf
    • Contact: Fabian J Brunner, MD; Email: fa.brunner@uke.de
    • Contact: Peter M Becher, MD; Email: m.becher@uke.de
  • Munich, Germany, 80636
    • Recruiting
    • Deutsches Herzzentrum München
    • Contact: Salvatore Cassese, MD, PHD; Phone Number: 2764 +49 89 1218; Email: cassese@dhm.mhn.de
    • Principal Investigator: Jens Wiebe, MD
    • Contact: Felix Voll, MD; Phone Number: 2749 +49 89 1218; Email: voll@dhm.mhn.de
  • Theodor-Stern-Kai 7
    • Frankfurt am Main, Theodor-Stern-Kai 7, Germany, D-60596
      • Recruiting
      • Universitätsklinikum Frankfurt
      • Contact: David M Leistner, Prof. MD; Email: david.leistner@herz-frankfurt.de
      • Contact: Lena Marie Seegers, MD; Email: lena.seegers@herz-frankfurt.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: homogenous; Stratification - homogenous pattern	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
Other: heterogenous; Stratification - homogenous pattern	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	all-cause death; myocardial infarction; target lesion revascularization (TLR)	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

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Collaborators: Abbott; EvidentIQ Germany GmbH; Institute of AI and Informatics in Medicine Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Stenosis; Coronary Artery Disease; Coronary Restenosis; Neointima
• Other Study ID Numbers: GE IDE no. BA00219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No