- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05434676
SOLUTION Trial in China
June 23, 2022 updated by: Genesis Medtech Corporation
Clinical Trial of The ShOckwave Medical Peripheral Lithoplasty® System Used to Treat Moderate and Severely CalcIfied FemOropopliteal Arteries in ChiNese Patients (SOLUTION Trial)
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
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Shanghai, China
- Zhongshan Hospital
-
Shanghai, China
- Huashan Hospital
-
Shanghai, China
- Affilated Hanzhou First People's Hospital, Zhejiang University School of Medicine
-
Shanghai, China
- Shanghai Jiaotong University School of Medicine,Renji Hospital
-
Shanghai, China
- Shanghai Jiaotong University School of Medicine,The Ninth People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: IVL group
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 or S4
|
To assess the safety and effectiveness of IVL treatment used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedural success
Time Frame: Immediately post index procedure
|
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
Time Frame: 30 days post index procedure
|
defined as:
|
30 days post index procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 15, 2021
Primary Completion (ACTUAL)
January 30, 2022
Study Completion (ANTICIPATED)
July 30, 2023
Study Registration Dates
First Submitted
June 15, 2022
First Submitted That Met QC Criteria
June 23, 2022
First Posted (ACTUAL)
June 28, 2022
Study Record Updates
Last Update Posted (ACTUAL)
June 28, 2022
Last Update Submitted That Met QC Criteria
June 23, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GM-PI-CIP002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Arterial Disease
-
University of NebraskaNot yet recruitingPeripheral Arterial Disease | Peripheral Vascular Diseases | Peripheral Arterial Occlusive Disease | Peripheral Artery DiseaseUnited States
-
CID S.p.A.Meditrial Europe Ltd.Not yet recruitingPeripheral Arterial Occlusive Disease | Peripheral Artery DiseaseItaly
-
Marissa JarosinskiRecruitingPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Clopidogrel, Poor Metabolism of | Artery DiseaseUnited States
-
Stanford UniversityTerminatedPAD - Peripheral Arterial Disease | PVD- Peripheral Vascular DiseaseUnited States
-
Vascuros Medical Pte LtdNovella ClinicalUnknownPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery DiseaseSingapore, Belgium, Germany
-
Western Vascular Institute, IrelandRecruitingPeripheral Arterial Occlusive DiseaseIreland
-
Jena University HospitalAngioDroid s.r.l., Bologna (Italy)CompletedPeripheral Arterial Occlusive DiseaseGermany
-
Seoul National University HospitalAstellas Pharma Korea, Inc.CompletedPeripheral Arterial Occlusive DiseaseKorea, Republic of
-
Heidelberg UniversityTerminatedPeripheral Arterial Occlusive DiseaseGermany
-
Johann Wolfgang Goethe University HospitalSuspendedPeripheral Arterial Occlusive DiseaseGermany
Clinical Trials on Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4
-
Shockwave Medical, Inc.CompletedPeripheral Arterial Disease | Vascular Disease, PeripheralNew Zealand, Australia, United States
-
Yale UniversityUniversity Hospitals Cleveland Medical Center; Shockwave Medical, Inc.RecruitingPeripheral Arterial Disease | Claudication | Critical Limb Ischemia | Femoral Arterial CalcificationUnited States
-
Rede Optimus Hospitalar SAShockwave Medical, Inc.Not yet recruitingThoracoabdominal Aortic Aneurysm, Without Mention of Rupture | Abdominal Aortic Aneurysm Without Rupture | Thoracic Aortic Aneurysm Without Rupture
-
Genesis Medtech CorporationActive, not recruiting
-
First Affiliated Hospital of Guangxi Medical UniversityRecruiting
-
Cardiovascular and Interventional Radiological...Shockwave Medical, Inc.Not yet recruitingChronic Limb-Threatening Ischemia
-
Cardiac Research Institute BVCompletedCoronary Artery Disease | Chronic Coronary InsufficiencySpain
-
Dr. Sabrina OverhagenRecruitingPeripheral Arterial Disease | Superficial Femoral Artery Stenosis | Calcifications VascularGermany
-
Shockwave Medical, Inc.RecruitingCoronary Artery DiseaseUnited States, Spain
-
Shockwave Medical, Inc.Active, not recruitingPeripheral Arterial DiseaseNew Zealand, Australia