NCT05544864

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-09-28
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2022-09-19
• Last updated: 2025-01-06

Locations

5 sites across 2 countries: Germany, Spain