Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-22 @ 1:54 PM
Study NCT ID:
NCT02996318
Status:
COMPLETED
Last Update Posted:
2021-08-27
First Post:
2016-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon
Sponsor:
InnoRa GmbH
Organization:
Study Overview
Official Title:
Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
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:
FIMLIMUSDCB
Brief Summary:
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.
Detailed Description:
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.
Patient population will consist of male and female adults suffering from coronary drug-eluting stent (DES) restenosis, which is to be treated by a study balloon according to the inclusion and exclusion criteria as defined below.
In Late lumen loss lesion (difference between the angiographic in-lesion MLD post procedural and at 6 months follow-up) will be evaluated by quantitative coronary angiography (QCA).
The study will be performed as a single-blind, SQP controlled study in 4 - 6 study centers in 50 patients.
Patient population will consist of male and female adults suffering from coronary drug-eluting stent (DES) restenosis, which is to be treated by a study balloon according to the inclusion and exclusion criteria as defined below.
In Late lumen loss lesion (difference between the angiographic in-lesion MLD post procedural and at 6 months follow-up) will be evaluated by quantitative coronary angiography (QCA).
The study will be performed as a single-blind, SQP controlled study in 4 - 6 study centers in 50 patients.
Study Oversight
Has Oversight DMC:
True
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?: