Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair

Safety & Feasibility Study of the Innovasc Tack Intravascular Staple System (Tack) for Securing Vascular Flaps Resulting From Balloon Angioplasty in the Infrainguinal Artery(Ies)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease; Critical Limb Ischemia
• Intervention / Treatment: Device: Innovasc Tack Intravascular Staple System (Tack)

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Asunción, Paraguay
    • Italian Hospital (Final treatment hospital and all follow-up)
  • Asunción, Paraguay
    • Santa Clara Medical Center (initial treatment hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >18 and < 85 years
• Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
• Patient has documented chronic limb ischemia with Rutherford Category 2, 3, 4, or 5. Clinical conditions of claudication or rest pain or ischemic ulceration or minor gangrene as diagnosed by the investigator
• Reference vessel diameter between 2 and 7mm
• Target lesion is not severely calcified
• At least one patent tibial runoff vessel is present.
• Patient has patent iliac or femoral arteries that allow endovascular access to the site with the Introducer Sheath or Delivery Catheter or these can be treated at the time of the procedure and achieve a <30% residual stenosis at each inflow lesion.
• Ability to pass the guidewire across the atherosclerotic lesion.
• No evidence of aneurysm or acute thrombus in target vessel.

Exclusion Criteria:

• Severe or infected gangrene of the lower extremity
• Planned major amputation
• Previously implanted stent at the treatment site
• Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization.
• Patient has connective tissue disease (e.g., Marfan's syndrome).
• Inability to tolerate antiplatelet agents
• Patient is hypercoagulable
• Patient has allergy to vascular contrast for which they cannot be premedicated.
• Patient is in acute renal failure or chronic renal insufficiency or failure as measured by a serum creatinine of >2.2 mg/dL.
• Patient has active systemic infection
• Patient has a less than one year life expectancy.
• Patient is pregnant or nursing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post Angioplasty Dissection Repair; Implant of Innovasc Tack Intravascular Staple System (Tack) to repair post angioplasty dissections	Device: Innovasc Tack Intravascular Staple System (Tack); Tack-It Dissection repair; Other Names: Intact Vascular Tack-It; Tack-It Endovascular Dissection Repair System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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: 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.	Conclusion of implant procedure

Other Outcome Measures

Outcome Measure	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.	30 and 90 days

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Principal Investigator: Adrian Ebner, MD, Santa Clara Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: angioplasty; dissections
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease
• Other Study ID Numbers: 2009-A