Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-28 @ 8:40 PM
Study NCT ID:
NCT02044003
Status:
COMPLETED
Last Update Posted:
2021-04-05
First Post:
2014-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair
Sponsor:
Philips Clinical & Medical Affairs Global
Organization:
Study Overview
Official Title:
Safety & Feasibility Study of the Innovasc Tack Intravascular Staple System (Tack) for Securing Vascular Flaps Resulting From Balloon Angioplasty in the Infrainguinal Artery(Ies)
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:
None
Brief Summary:
The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the infrainguinal due post-angioplasty dissection.
Detailed Description:
The primary objective of the study is to evaluate the safety of delivery and placement of the Innovasc Tack Intravascular Staple System on vascular flaps in the SFA, created by percutaneous transluminal balloon angioplasty
Safety will be evaluated as the 30-day (or hospital discharge date, whichever is longer) rate of major adverse events defined as the composite endpoint of death, device embolization, the occurrence of surgery related to the device, device related occlusion of the artery, or major unplanned amputation of the ipsilateral lower extremity.
The secondary objective is to evaluate the feasibility of using the Innovasc Tack Intravascular Staple System to permanently secure vascular flaps.
Secondary Evaluation of Feasibility (technical success) of the Innovasc Tack Intravascular Staple System (procedure and device) will be evaluated acutely by the following:
* Feasibility is defined as the ability to accurately place the Plaque Tacks and resolve post-PTA dissection flaps prior to the conclusion of the procedure, as demonstrated by angiography
* Acute technical success: Acute luminal patency during the revascularization procedure using standard angiography which demonstrates that the lumen of the artery at the location of tack implant remains patent at the conclusion of the procedure.
The additional objectives of the study are to assess additional parameters as follows:
* Long term success will be assessed at one (1) month and three (3) months by evaluation of post-implant stability of the Plaque Tack relative to vascular or external landmarks at 30 days and 3 months via standard x-ray.
* Patency at 30 days and 3 months via duplex scanning or angiography, whichever deemed most appropriate for follow up of each individual patient by the principal investigator.
Safety will be evaluated as the 30-day (or hospital discharge date, whichever is longer) rate of major adverse events defined as the composite endpoint of death, device embolization, the occurrence of surgery related to the device, device related occlusion of the artery, or major unplanned amputation of the ipsilateral lower extremity.
The secondary objective is to evaluate the feasibility of using the Innovasc Tack Intravascular Staple System to permanently secure vascular flaps.
Secondary Evaluation of Feasibility (technical success) of the Innovasc Tack Intravascular Staple System (procedure and device) will be evaluated acutely by the following:
* Feasibility is defined as the ability to accurately place the Plaque Tacks and resolve post-PTA dissection flaps prior to the conclusion of the procedure, as demonstrated by angiography
* Acute technical success: Acute luminal patency during the revascularization procedure using standard angiography which demonstrates that the lumen of the artery at the location of tack implant remains patent at the conclusion of the procedure.
The additional objectives of the study are to assess additional parameters as follows:
* Long term success will be assessed at one (1) month and three (3) months by evaluation of post-implant stability of the Plaque Tack relative to vascular or external landmarks at 30 days and 3 months via standard x-ray.
* Patency at 30 days and 3 months via duplex scanning or angiography, whichever deemed most appropriate for follow up of each individual patient by the principal investigator.
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?: