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Safety and Efficacy of the DEVOIR Sirolimus-Coated Coronary Balloon in the Real-world Clinical Practice

CAD Clinical Trial

Official title:
Assessment of Safety and Efficacy of the DEVOIR Sirolimus-Coated Balloon for the Treatment of Native Coronary Artery Lesions in the Real-world Clinical Practice

Clinical Trial Summary

The study is a prospective, non-randomized, multicenter, post-marketing surveillance study evaluating the CE-marked DEVOIR Sirolimus-Coated Coronary Balloon in 4 subgroups regarding device approved indications:

- In-stent restenosis lesions: either bare metal or drug eluting stent restenosis

- Bifurcation lesions (with drug-eluting stent in main branch and drug-coated balloon in side branch): treatment of lesion of all Medina types except (0,0,1) in native coronary arteries

- Small vessels: treatment of lesions ≤2.75 mm

- BMS implantation followed by DCB inflation

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02853994
Study type Observational
Source MINVASYS
Contact
Status Not yet recruiting
Phase N/A
Start date September 2016
Completion date September 2018
View Details
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