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

Coronary Artery Disease Clinical Trial

— ISAR-DESIRE5  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05544864
• Other study ID #: GE IDE no. BA00219
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2022
• Est. completion date: September 2026

Study information

• Verified date: March 2024
• Source: Deutsches Herzzentrum Muenchen
• Contact: Felix Voll, MD
• Phone: +49 89 1218
• Email: voll[@]dhm.mhn.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 376
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Restenosis
• Neointima
• Restenoses, Coronary

Intervention

Device:
• Drug eluting stent (DES)
DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)
• Drug coated ballloon (DCB)
DCB angioplasty with any commercially available drug-coated balloon

Locations

Country	Name	City	State
Germany	Universitätsklinikum Frankfurt	Frankfurt am Main	Theodor-Stern-Kai 7
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Deutsches Herzzentrum München	Munich

Sponsors (4)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	Abbott, EvidentIQ Germany GmbH, Institute of AI and Informatics in Medicine Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR		24 months of clinical follow-up after randomization
Secondary	Individual endpoints of the composite endpoints	all-cause death; myocardial infarction; target lesion revascularization (TLR)	24 months of clinical follow-up after randomization
Secondary	Stent thrombosis according to the ARC criteria		24 months of clinical follow-up after randomization
Secondary	Safety endpoint: a composite endpoint of all-cause death and myocardial infarction		24 months of clinical follow-up after randomization