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
NCT ID: NCT05544864
Last Updated: 2025-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
376 participants
INTERVENTIONAL
2022-09-28
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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homogenous
Stratification - homogenous pattern
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
heterogenous
Stratification - homogenous pattern
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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EvidentIQ Germany GmbH
UNKNOWN
Abbott
INDUSTRY
Technical University of Munich
OTHER
Deutsches Herzzentrum Muenchen
OTHER
Responsible Party
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Locations
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Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Elisabeth-Krankenhaus Essen GmbH
Essen, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Deutsches Herzzentrum München
Munich, , Germany
Hospital Universitario de La Princesa Madrid
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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 Jun 30. doi: 10.1007/s12265-025-10650-x. Online ahead of print.
Other Identifiers
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GE IDE no. BA00219
Identifier Type: -
Identifier Source: org_study_id
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