A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries … (NCT03807531) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee
Germany, New Zealand, Switzerland100 participantsStarted 2019-07-11
Plain-language summary
The purpose of this study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS). The TSS is intended for use in conjunction with a commercially available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.
This study is a prospective, non-randomized, multicenter, single arm trial, with sites in New Zealand, Germany, and Switzerland.
At least two and no more than 10 sites are expected to participate, with 100 subjects enrolled (no more than 40 at a single site).
The study follow up will take place over a period of 365 days. A vessel recoil substudy will be included for a select group of subjects.
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 and able to comply with the study protocol.
. Life expectancy \>1 year in the investigator's opinion
. Subject is \> 18 years of age.
. Subject is Rutherford class 3-5.
. Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed with a guidewire.
. Target lesion must meet lesion-specific criteria in pre-screening by angiography (pre-screening with CTA, MRA or selective angiography may be performed prior to the index procedure)
. Target vessel(s) reconstitutes(s) at or above the medial malleolus, with the target treated segment extending no more than 10 mm beyond the medial malleolus.
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
Primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization)
Timeframe: 6 months
2
Freedom from device and procedure-related death through 30 days post-procedure