Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04511247
Status:
RECRUITING
Last Update Posted:
2023-03-27
First Post:
2020-08-05
Brief Title:
SirolimUs CoaTed Balloon for The TrEatment of Below The Knee Arterial Disease
Sponsor:
Concept Medical Inc
Organization:
Concept Medical Inc
Study Overview
Official Title:
FUTURE BTK Randomized Controlled Trial of First SirolimUs CoaTed Balloon VersUs StandaRd Balloon Angioplasty in The TrEatment of Below The Knee Arterial Disease
Status:
RECRUITING
Status Verified Date:
2023-03
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:
FUTURE-BTK
Brief Summary:
This study aims to conduct a randomized double blind randomised controlled multicentre trial of sirolimus drug coated balloon versus standard percutaneous transluminal angioplasty for the treatment of below the knee arterial disease
Detailed Description:
The burden of limb loss as a result of peripheral arterial disease PAD is high and this problem is set to worsen globally Treatment of PAD primarily involves revascularisation of the limb Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by most vascular centers Local drug delivery using drug coated balloons DCB during angioplasty for PAD can successfully deliver effective local tissue concentrations of anti-proliferative drugs to the lesions in the artery involved in the PAD This offers the potential for sustained anti-restenotic efficacy
Randomized trials have shown superiority of Paclitaxel DCBs over just plain-balloon angioplasty for treatment of PAD and DCB is now considered the standard of care However a recent meta-analyses which showed increased mortality at two years in patients treated with paclitaxel DCBs have called into question the safety of paclitaxel based DCBs
Alternative drugs for DCBs are therefore urgently needed and sirolimus offers an attractive alternative Compared to Paclitaxel sirolimus is cytostatic in its mode of action with a high margin of safety It has a high transfer rate to the vessel wall and has been shown to effectively inhibit neointimal hyperplasia in the porcine coronary model In the coronary artery interventions preliminary clinical studies using Sirolimus DCBs have also shown excellent procedural and 6 month patency
Randomized trials have shown superiority of Paclitaxel DCBs over just plain-balloon angioplasty for treatment of PAD and DCB is now considered the standard of care However a recent meta-analyses which showed increased mortality at two years in patients treated with paclitaxel DCBs have called into question the safety of paclitaxel based DCBs
Alternative drugs for DCBs are therefore urgently needed and sirolimus offers an attractive alternative Compared to Paclitaxel sirolimus is cytostatic in its mode of action with a high margin of safety It has a high transfer rate to the vessel wall and has been shown to effectively inhibit neointimal hyperplasia in the porcine coronary model In the coronary artery interventions preliminary clinical studies using Sirolimus DCBs have also shown excellent procedural and 6 month patency
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None