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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Elisabeth-Krankenhaus Essen GmbH
RECRUITING
Essen
Universitätsklinikum Frankfurt
RECRUITING
Frankfurt Am Main
Universitätsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Deutsches Herzzentrum München
RECRUITING
Munich
Spain
Hospital Universitario de La Princesa Madrid
RECRUITING
Madrid
Contact Information
Primary
Felix Voll, MD
voll@dhm.mhn.de
+49 89 1218 2749
Backup
Salvatore Cassese, MD, PHD
cassese@dhm.mhn.de
+49 89 1218 2764
Time Frame
Start Date: 2022-09-28
Estimated Completion Date: 2026-09
Participants
Target number of participants: 376
Treatments
Other: homogenous
Stratification - homogenous pattern
Other: heterogenous
Stratification - homogenous pattern
Related Therapeutic Areas
Sponsors
Collaborators: EvidentIQ Germany GmbH, Technical University of Munich, Abbott
Leads: Deutsches Herzzentrum Muenchen