SOLUTION Trial in China

NCT05434676 | Unknown

• 1 other identifier: GM-PI-CIP002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

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

Conditions

Peripheral Arterial Disease; Calcifications Vascular

Outcome Measures

Primary Outcomes (2)

• Procedural success

  defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) post IVL treatment (prior to DCB)by angiographic core lab

  Immediately post index procedure

• Major Adverse Event (MAE) at 30 days

  defined as: * Need for emergency surgical revascularization of target limb * Unplanned target limb major amputation (above the ankle) * Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization * Perforations that require an intervention, including bail-out stenting

  30 days post index procedure

Study Arms (1)

IVL group

EXPERIMENTAL

Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 or S4

Device: Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4

Interventions

Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4 DEVICE

To assess the safety and effectiveness of IVL treatment used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries

IVL group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genesis Medtech Corporation: lead

Study Sites (5)

Affilated Hanzhou First People's Hospital, Zhejiang University School of Medicine

Shanghai, China

Location

Huashan Hospital

Shanghai, China

Location

Shanghai Jiaotong university school of medicine，Renji Hospital

Shanghai, China

Location

Shanghai Jiaotong University School of Medicine，The Ninth People's Hospital

Shanghai, China

Location

Zhongshan Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Vascular Calcification

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 28, 2022
• Study Start: June 15, 2021
• Primary Completion: January 30, 2022
• Study Completion: July 30, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)