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Peripheral Arterial DiseaseNCT05434676

SOLUTION Trial in China

A study testing Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4 in people with Peripheral Arterial Disease and Calcifications Vascular, run by Genesis Medtech Corporation at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
5 sitesChina
Study dates
15 Jun 2021to 30 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

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

    Shanghai

  • Huashan Hospital

    Shanghai

  • Shanghai Jiaotong university school of medicine，Renji Hospital

    Shanghai

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

    Shanghai

  • Zhongshan Hospital

    Shanghai

Other trials in China

About this study

Official title: 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

Being tested
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4
Medical subject headings
Peripheral Arterial Disease, Vascular Calcification

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4Device

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

Study groups in NCT05434676
Study groupRoleWhat they receive
IVL groupExperimentalShockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 or S4
Receives: Device: Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedural success

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

    Measured: Immediately post index procedure

  2. 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

    Measured: 30 days post index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2022
  2. Study start15 Jun 2021
  3. Primary completion30 Jan 2022
  4. Study completion30 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05434676
Sponsor's protocol ID
GM-PI-CIP002
Status last verified
Jun 2022
First submitted
15 Jun 2022
Last updated
28 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4 in people with Peripheral Arterial Disease and Calcifications Vascular, run by Genesis Medtech Corporation at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural success (time frame: Immediately post index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05434676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.

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