Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries (NCT03192696) | Clinical Trial Compass
CompletedNot Applicable
Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries
United States127 participantsStarted 2017-10-19
Plain-language summary
A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.
Who can participate
Age range
18 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:
* Subject is \>18 years old;
* Subject is willing and able to give informed consent;
* Subject has Rutherford Classification of I-V;
* Subject presenting with a single Class I, II or III ISR lesion as per Tosaka's Classification criteria in the lower leg extremities;
* Target lesion must be \>70% stenosed and within a stented segment by angiographic visual estimation;
* Reference vessel lumen acceptable for treatment with Pantheris catheter size as per visual angiographic estimation;
* Target lesions must be within the stented segment and no more than 3 cm past the proximal or distal portions of the stent;
* Target lesion is ≤30 cm in length;
* Intraluminal crossing of totally occluded lesions prior to atherectomy;
* At least one patent tibial run-off vessel at baseline; and
* Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days, 6 months and 12 months.
Exclusion Criteria:
* Subject is pregnant or breast feeding;
* Rutherford Class 0 or VI;
* Severe calcification of the target lesion;
* Acute ischemia and/or acute thrombosis of the target lesion segment;
* Target lesion with a covered stent;
* Target lesion in the iliac artery;
* Target lesion stenosis \<70%;
* Target lesion \>30 cm in length;
* Subjects with totally occluded stented segments that are not successfully crossed intraluminally prior to atherectomy treatment;
* Grade 4 or 5 stent fracture affecting target stent, or where evidence of stent protr…
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.
What they're measuring
1
Freedom from a composite of major adverse events (MAEs) through 30-day follow-up (safety)
Timeframe: Day 0 through 30 days post treatment procedure
2
Technical success of Pantheris catheter treatment (efficacy) device