Vessel Recoil in Specific CLTI Populations (NCT07465627) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Vessel Recoil in Specific CLTI Populations
40 participantsStarted 2026-03
Plain-language summary
Chronic limb threatening ischemia (CLTI) represents the most advanced stage of peripheral arterial disease (PAD) and is characterized by ischemic rest pain, non-healing wounds, or ischemic gangrene. High-risk PAD populations including patients with end-stage renal disease and or diabetes also experience worse outcomes with significantly increased rates of amputation and mortality.
Although some patients with PAD are best treated with a combination of medical management, exercise and lifestyle modification, revascularization is indicated in those with advanced stages of disease and particularly in the presence of CLTI. Revascularization of below-the-knee (BTK) arteries is required for most patients suffering from CLTI, but treatment faces numerous challenges comprising calcification, small vessel size, long-lesion length and early elastic recoil. With regard to these challenges, numerous innovative techniques and devices have been developed within the past decades to optimize endovascular treatment of BTK vessels.
The Spur Peripheral Retrievable Scaffold System (Spur) was developed to directly address many of these pitfalls of infrapopliteal arterial disease. The premise of the design of the Spur is to provide temporary mechanical scaffolding and to prepare the vessel for treatment with a drug-coated balloon (DCB) to enhance drug absorption by creating channels in the endothelium by the deployed Spur.
The objective of this study is to perform a prospective, single-center, single-arm, non-randomized study to evaluate acute vessel recoil following BTK treatment with the Spur Retrievable Scaffold System in combination with a commercially available DCB in specific patients populations. Specific patient populations that are selected to participate in this study are either at high risk to discover unfavorable outcomes with standard techniques due to a high complexity of lesions and/or patients that are not adequately mirrored in available studies. The patient cohorts that will be studied are diabetics and patients on hemodialysis (for at least 6 months). As women are commonly under-represented in comparable trials, this study requires at least 50% of women for each cohort.
The primary endpoint is vessel recoil within 15 minutes post treatment assessed with angiography. Secondary endpoints will be followed out to 12 months.
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 willing and able to provide informed consent
. Subject is able to comply with the study protocol and with follow-up
. Life expectancy \>1 year in the investigator's opinion
. Subject is \> 18 years of age
. Subject must have symptoms of limb ischemia, determined by clinical symptoms of RC 4 or 5, including rest pain (RC 4) and/or minor tissue loss (RC 5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation
. Subject has stenotic, restenotic or occlusive lesions located in BTK vessels in pre-screening with CTA, MRA or angiography prior to the index procedure.
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.
. Subject suffers from diabetes and/or receives chronic hemodialysis for KD (for at least 6 months)
. Target lesion can be successfully crossed with a guidewire.
Exclusion criteria
. Subject is unwilling or unlikely to comply with the duration of the study (up to 12 months +/-30 days post intervention) in the opinion of the investigator
. Subject is pregnant or planning to become pregnant during the course of the trial
. Subject is breastfeeding or planning to breastfeed during the course of the trial
. Subject has an active and uncontrolled systemic infection, including septicemia or bacteremia
. Subject has documented active osteomyelitis proximal to the phalanges of the target limb. Osteomyelitis in the digit(s) of the target foot is permitted.
. Subject has a wound above the ankle and/or a heel wound
. Subject has planned or had previous major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal amputation or digit amputation) is permitted.
. Subject with poor and insufficient general condition and/or comorbidities not allowing for endovascular treatment as per the investigator's discretion