Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT02853994
Status:
UNKNOWN
Last Update Posted:
2016-08-03
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the DEVOIR Sirolimus-Coated Coronary Balloon in the Real-world Clinical Practice
Sponsor:
MINVASYS
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
* 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: