Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
The additional objectives of the study are to assess additional parameters as follows:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post Angioplasty Dissection Repair | Experimental | Implant of Innovasc Tack Intravascular Staple System (Tack) to repair post angioplasty dissections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Innovasc Tack Intravascular Staple System (Tack) | Device | Tack-It Dissection repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Safety | 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Feasibility | Feasibility (technical success) of the Innovasc Tack Intravascular Staple System (procedure and device) will be evaluated acutely by the following:
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of post-implant stability | Evaluation of post-implant stability of the Tack relative to vascular or external landmarks at 30 days and 3 months via standard x-ray. | 30 and 90 days |
| Patency | 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adrian Ebner, MD | Santa Clara Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Italian Hospital (Final treatment hospital and all follow-up) | Asunción | Paraguay | ||||
| Santa Clara Medical Center (initial treatment hospital) |
Not provided
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conclusion of implant procedure |
| 30 and 90 days |
| Asunción |
| Paraguay |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |