Status:
UNKNOWN
SOLUTION Trial in China
Lead Sponsor:
Genesis Medtech Corporation
Conditions:
Peripheral Arterial Disease
Calcifications Vascular
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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
Eligibility Criteria
Inclusion
- General
- Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
- Age of subject is \> 18 and ≤80, male or female.
- Rutherford Category 2 to 5 of the target limb (If both limbs are eligible for the study, one limb will be selected as the target limb at the discretion of the investigator)
- Estimated life expectancy \>1 year.
- Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
- Subject is intended to undergo treatment with IVL followed by DCB. Angiographic
- Target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery
- Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
- Target lesion is ≥70% stenosis by investigator via visual estimate.
- Target lesion length is ≤180mm for lesions 70-99% stenosed. Target lesion can be all or part of the 180mm treated zone.
- Chronic total occlusion (CTO), lesion length is ≤100mm of the total ≤180mm target lesion.
- Subject has at least one patent tibial vessel on the target leg with runoff to the foot, defined as no stenosis \>50%.
- Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending \> 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is \<50mm in length.
Exclusion
- 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.
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05434676
Start Date
June 15 2021
End Date
July 30 2023
Last Update
June 28 2022
Active Locations (5)
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1
Affilated Hanzhou First People's Hospital, Zhejiang University School of Medicine
Shanghai, China
2
Huashan Hospital
Shanghai, China
3
Shanghai Jiaotong university school of medicine，Renji Hospital
Shanghai, China
4
Shanghai Jiaotong University School of Medicine，The Ninth People's Hospital
Shanghai, China