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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.