Trials / Unknown
UnknownNCT02853994
Safety and Efficacy of the DEVOIR Sirolimus-Coated Coronary Balloon in the Real-world Clinical Practice
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- MINVASYS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2018-09-01
- Completion
- 2018-09-01
- First posted
- 2016-08-03
- Last updated
- 2016-08-03
Source: ClinicalTrials.gov record NCT02853994. Inclusion in this directory is not an endorsement.