Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System (NCT05007925) | Clinical Trial Compass
CompletedNot Applicable
Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System
United States, Germany250 participantsStarted 2021-11-18
Plain-language summary
To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries.
Post-market, prospective , multi-center, single-arm study.
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
. Age of subject is ≥ 18.
. Subject is able and willing to comply with all assessments in the study.
. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
. Critical limb ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 4-5; or Rutherford 3 in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure.
. Estimated life expectancy \>1 year.
. Up to 2 below-the-knee target lesion(s) in native vessels in one or both limbs.
. Target lesion reference vessel diameter (RVD) between 2.0 mm and 4.0 mm by investigator visual estimate.
. Target lesion with ≥70% stenosis by investigator visual estimate.
Exclusion criteria
. Rutherford Category 0, 1, 2 or 6 (target limb).
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
Number of Participants With Procedure Success
Timeframe: 30 days
2
Number of Participants With Major Adverse Limb Events (MALE) + Post-Operative Death (POD)
Timeframe: 30 days
3
Subjects Without Serious Angiographic Complications
. Osteomyelitis or deep soft tissue infection extending proximal from the metatarsals that cannot be treated with an individual toe ray amputation or transmetatarsal amputation (TMA) .
. History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure.
. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
. Subject has known allergy to urethane, nylon, or silicone.
. Myocardial infarction within 30 days prior to enrollment.
. History of stroke within 60 days prior to enrollment.