Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA (NCT03455855) | Clinical Trial Compass
CompletedNot Applicable
Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA
China72 participantsStarted 2018-03-05
Plain-language summary
This clinical study is a prospective, non-randomized, multicenter, single-arm study to demonstrate the acceptable safety and performance of the JETSTREAM™ Atherectomy System (Jetstream) used during percutaneous peripheral vascular intervention in patients with occlusive atherosclerotic lesions in the native SFA and/or PPA. It is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Jetstream System.
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
. Subjects age 18 and older
. Subject or the subject's legal representative is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits
. Subject has documented chronic, symptomatic lower limb ischemia defined as Rutherford categories 2 - 4, and is eligible for percutaneous peripheral vascular intervention
. Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA, and meet all of following angiographic criteria by visual assessment:
. Patent infrapopliteal and popliteal artery, i.e., single distal runoff or better with at least one of three vessels patent (\< 50% stenosis by visual assessment) to the ankle or foot with no planned intervention
Exclusion criteria
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
The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter Stenosis
Timeframe: Index Procedure (Core-lab will analysis the procedural angiograms to assess the acute reduction of percent diameter stenosis (%DS))
2
The Primary Safety Endpoint-The Rate of Major Adverse Event (MAE) at 30 Days Follow up
. Target lesion is located in the iliac artery or above the SFA
. Target lesion stenosis \< 70%
. Target lesion is moderately to severely angulated (\> 30°) or torturous at treatment segment
. Target lesion/vessel previously treated with drug-coated balloon within 12 months prior to the index procedure
. Target lesion/vessel previously treated with atherectomy, laser or other debulking devices prior to the index procedure
. Target lesion/vessel with in-stent restenosis
. Subjects who have undergone prior surgery or endovascular intervention of SFA/PPA in the target limb to treat atherosclerotic disease within 3 month prior to the index procedure
. Use of drug-coated devices, or laser or any other debulking devices other than Jetstream System (such as CTO devices or cutting balloon) in the target limb during the index procedure