First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Ste… (NCT06410313) | Clinical Trial Compass
RecruitingNot Applicable
First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease
United States, Australia30 participantsStarted 2024-08-15
Plain-language summary
This is a prospective, open label, multicenter, single arm, first in human clinical study.
Patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be enrolled. The patients will be treated with the ChampioNIR Stent System. All implanted patients will be followed up at 30 days and 6, 12, 24 and 36 months. The follow-up visits will include patency evaluation by duplex ultrasound
Who can participate
Age range
18 Years – 120 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 years and of age of legal consent.
. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index/toe-brachial index (ABI/TBI) \<0.90/0.80.
. A single superficial femoral artery lesion with \>50% stenosis or total occlusion.
. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≤ 150 mm.
. Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 5.0 mm by visual assessment.
. Target lesion located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda femoris (deep femoral artery).
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.
. Patent infra-popliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\<50% stenosis) to the ankle or foot.
. The target lesion(s) can be successfully crossed with a guide wire and dilated.
Exclusion criteria
. Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.
. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
. Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined \>50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoro-popliteal bypass graft and was not successfully treated prior to treatment of the target lesion either within the same procedure or at least 30 days prior to the index procedure.
. Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.
. Presence of an ipsilateral arterial artificial graft.
. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
. Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
. Required stent placement (in the target or any other lesion) via a retrograde approach.