Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-02-28 @ 11:16 AM
Study NCT ID:
NCT02802306
Status:
COMPLETED
Last Update Posted:
2021-04-05
First Post:
2016-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tack Optimized Drug Coated Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries
Sponsor:
Philips Clinical & Medical Affairs Global
Organization:
Study Overview
Official Title:
Tack Optimized Drug Coated Balloon Angioplasty in the Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™
Status:
COMPLETED
Status Verified Date:
2021-04
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:
TOBA III
Brief Summary:
This is an Outside the United States, post-CE Mark, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System. This study will evaluate subjects with PAD who receive PTA (with a drug-coated balloon (DCB)) in the SFA and in popliteal arteries, ranging in diameter from 2.5mm to 6.0mm and lesion lengths of ≥20mm and ≤150mm, and have a resulting dissection(s) type(s) A through F. TOBA III will also evaluate the safety and efficacy of the device when used to treat a sub-group presenting with longer lesions of \>150mm and ≤250mm.
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?: