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

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ClinicalTrials.gov Identifier: NCT02044003
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : January 23, 2014
Sponsor:
Information provided by (Responsible Party):
Intact Vascular

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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Peripheral Artery Disease Device: Innovasc Tack Intravascular Staple System (Tack) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : December 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

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




Primary Outcome Measures :
  1. Evaluation of Safety [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. Evaluation of Feasibility [ Time Frame: Conclusion of implant procedure ]

    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.


Other Outcome Measures:
  1. Evaluation of post-implant stability [ Time Frame: 30 and 90 days ]
    Evaluation of post-implant stability of the Tack relative to vascular or external landmarks at 30 days and 3 months via standard x-ray.

  2. Patency [ Time Frame: 30 and 90 days ]
    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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044003


Locations
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Paraguay
Italian Hospital (Final treatment hospital and all follow-up)
Asunción, Paraguay
Santa Clara Medical Center (initial treatment hospital)
Asunción, Paraguay
Sponsors and Collaborators
Intact Vascular
Investigators
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Principal Investigator: Adrian Ebner, MD Santa Clara Medical Center

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Responsible Party: Intact Vascular
ClinicalTrials.gov Identifier: NCT02044003     History of Changes
Other Study ID Numbers: 2009-A
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014
Keywords provided by Intact Vascular:
angioplasty
dissections
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Ischemia
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases