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Peripheral Arterial DiseaseNCT02369848

Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2)

A study testing Shockwave Lithoplasty System in people with Peripheral Arterial Disease, run by Shockwave Medical, Inc. at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the safety and performance of the Shockwave Lithoplasty™ System in subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm reference vessel diameter at the target site. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
Shockwave Lithoplasty System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
8 sitesin 3 countries
Study dates
Jun 2015to Dec 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is able and willing to comply with all assessments in the study.
  • 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.
  • Rutherford Clinical Category 2, 3, or 4.
  • Resting ankle-brachial index (ABI) of ≤0.90, or ≤0.75 after exercise, of the target leg.
  • Estimated life expectancy >1 year.
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  • Angiographic Inclusion Criteria:
  • Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
  • Target lesion that is located in a native de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery).
  • Target lesion reference vessel diameter is between 3.50mm and 7.0mm by visual estimate.
  • Target zone is ≤150mm in length. Target lesion can be all or part of the 150mm zone.
  • Target lesion is ≥70% stenosis by investigator via visual estimate.
  • Subject has at least one patent tibial vessel on the target leg with runoff to the ankle (not supported by collateral circulation.) Tibial vessel patency is defined as no stenosis >50%.
  • Ability to pass the guidewire across the atherosclerotic lesion.
  • No evidence of aneurysm or acute or chronic thrombus in target vessel.
  • Calcification is at least moderate. (Presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion.)

Who cannot join

  • Rutherford Clinical Category 5 and 6.
  • Subject has active infection in the target leg.
  • Planned major amputation of the target leg (transmetatarsal or higher).
  • The use of chronic total occlusion (CTO) re-entry devices.
  • CTOs greater than 80 mm in length.
  • Any in-stent restenosis within the target zone.
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  • Lesions within 10 mm of ostium of the SFA.
  • Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
  • Target lesion within native or synthetic vessel grafts.
  • History of prior endovascular or surgical procedure on the index limb within the past 30 days.
  • Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated with Plain old Balloon Angioplasty (POBA) or stent and without complications.
  • Subject requires treatment of a peripheral lesion on the ipsilateral limb distal and beyond the 150mm target zone at the time of the enrollment/index procedure.
  • Subject has a known coagulopathy or has a bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter, or International Normalized Ratio (INR) >1.5.
  • Subject in whom antiplatelet, anticoagulant, or thrombolytic 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 unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
  • History of thrombolytic therapy within two weeks of enrollment.
  • Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L), or on dialysis.
  • Subject is pregnant or nursing.
  • Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) 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.

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Germany4 sites

  • Universitäts-Herzzentrum Freiburg & Bad Krozingen

    Bad Krozingen

  • University Leipzig Medical Centre

    Leipzig

  • St. Franziskus Hospital

    Münster

  • RoMed Klinikum Rosenheim

    Rosenheim

Other trials in Germany

Austria3 sites

  • Universitätsklinikum LKH Graz

    Graz

  • Hanusch Krankenhaus

    Vienna

  • Medizinische Universitat Wien

    Vienna

Other trials in Austria

New Zealand1 site

  • Auckland City Hospital

    Auckland

Other trials in New Zealand

About this study

Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the safety and performance of the Shockwave Lithoplasty™ System in subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm reference vessel diameter at the target site. The Shockwave Lithoplasty™ System is indicated to generate sonic shockwave energy within the target treatment site and disrupt calcium within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low balloon pressure. Up to sixty (60) subjects will be enrolled and treated with Lithoplasty to yield thirty (51) evaluable subjects complete the study assuming a 15% lost to follow-up rate.

Read the detailed description

Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the safety and performance of the Shockwave Lithoplasty™ System in subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm reference vessel diameter at the target site. The Shockwave Lithoplasty™ System is indicated for lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to sixty (60) subjects will be enrolled at up to 8 centers in Europe and New Zealand to yield at least 51 evaluable subjects (assuming a lost-to-follow up rate of 15%).

Subjects will be evaluated at discharge, 30 days, 6 months, and 12 months after enrollment/index procedure.

Primary endpoints include safety and efficacy. Safety is a composite of new-onset Major Adverse Events through 30 days. Efficacy is target lesion patency at 12 months by duplex ultrasound defined as freedom from ≥50% restenosis.

Being tested
Shockwave Lithoplasty System
Medical subject headings
Peripheral Arterial Disease

What participants receive

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

  • Shockwave Lithoplasty SystemDevice

Study groups in NCT02369848
Study groupRoleWhat they receive
Lithoplasty TreatmentExperimentalShockwave Lithoplasty System
Receives: Device: Shockwave Lithoplasty System

What is being measured

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

  1. Effectiveness Endpoint Defined as Number of Participants withTarget Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis

    Measured: 12 months post-procedure

  2. Safety Endpoint Defined as Composite of New-onset Major Adverse Events (MAEs)

    Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion or distal to the treated lesion after the index procedure and results in extended hospitalization or noted angiographically, and requiring mechanical or pharmacologic means to improve flow and results in extended hospitalization.

    Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting.

    Measured: Within 30 days following procedure

Secondary outcomes (9)

  1. Safety Measured by Number of Participants With Freedom From Major Adverse Events (MAEs)

    Measured: 12 months

  2. Secondary Endpoint of Acute Procedural Success Achieved in Number of Participants

    1. The ability of the Shockwave Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty (PTA) therapy) as assessed by quantitative angiography via core lab evaluation.
    2. The ability of the Shockwave Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (without adjunctive PTA therapy) as assessed by quantitative angiography via core lab evaluation.

    Measured: Day of Procedure

  3. Secondary Patency Measured by Number of Participants With Target Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis.

    Measured: 6 months

  4. Secondary Patency Measured by Number of Participants With Target Lesion Patency (Without Adjunctive PTA) by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis.

    Measured: 12 months

  5. Clinical Success - Improvement of Ankle-Brachial Index (ABI) of the Target Limb.

    The ankle-brachial pressure index or ankle-brachial index is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD).

    Measured: 6 months

  6. Clinical Success - Improvement of Ankle-Brachial (ABI) of the Target Limb.

    The ankle-brachial pressure index or ankle-brachial index is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD).

    Measured: 12 months

  7. Clinical Success

    Change in Rutherford Clinical Category at from Baseline to 6 months.

    There are seven stages to consider:

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

    Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

    Measured: 6 months

  8. Clinical Success

    Change in Rutherford Clinical Category from Baseline to12 months.

    There are seven stages to condsider:

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

    Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

    Measured: 12 months

  9. Clinical Success

    Change in Rutherford Clinical Category from Baseline to 30 days

    There are seven stages to condsider:

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

    Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

    Measured: 30 days

Timeline

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

  1. First posted24 Feb 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2015
  4. Study completionDec 2016

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02369848
Sponsor's protocol ID
TD 0232
Status last verified
Mar 2018
First submitted
9 Feb 2015
Last updated
18 Apr 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Shockwave Lithoplasty System in people with Peripheral Arterial Disease, run by Shockwave Medical, Inc. at 8 sites in 3 countries.

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 16 inclusion and 24 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: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Austria, New Zealand. 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?

Yes. Results are posted in the registry (first posted 18 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Effectiveness Endpoint Defined as Number of Participants withTarget Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis (time frame: 12 months post-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 NCT02369848.

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 18 Apr 2018.

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