Status
Conditions
Treatments
About
This is a prospective, multicenter, single arm study, to support the safety and effectiveness assessment of the Shockwave Medical Peripheral IVL System applied to Chinese patients
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
General
Exclusion criteria
General
Subject has active infection requiring antibiotic therapy.
Planned target limb major amputation (above the ankle).
History of prior endovascular or surgical procedure on the index limb within the past 30 days or planned within 30 days of the index procedure.
Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter.
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 60 days prior to enrollment.
History of stroke within 60 days prior to enrollment.
History of thrombolytic therapy within two weeks of enrollment.
Serum creatinine greater than 2 times the upper reference limit
Subject is pregnant or nursing.
Women of childbearing potential (18 years to less than 2 years post-menopausal and not surgically sterile) with positive blood or urine pregnancy test at screening
Subject is participating in another research study that has not reached the primary endpoint.
Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post- treatment.
The use of specialty balloons (Scoring or cutting balloon), re-entry or atherectomy devices.
Angiographic
In-stent restenosis within 10mm of the target zone.
Lesions within 10mm of the ostium of the SFA or within 10mm of the ostium of the anterior tibial artery.
Evidence of aneurysm or thrombus in target vessel.
No calcium or mild calcium in the target lesion.
Target lesion within native or synthetic vessel grafts.
Subject has significant non-target lesion (>50% stenosis or occlusion) within target limb (e.g. iliac or common femoral) not successfully treated prior to treatment of the target lesion.
Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to target site at the time of the index procedure.
Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations.
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal