Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair (NCT02044003) | Clinical Trial Compass
CompletedNot Applicable
Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair
Paraguay11 participantsStarted 2009-12
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mea…