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

NCT02853994 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2016-08-03

No results posted yet for this study

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

Sponsors & Collaborators

  • MINVASYS

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-09-30
Completion
2018-09-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02853994 on ClinicalTrials.gov