Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2)

NCT02369848 | Completed Results FDA Device

• 1 other identifier: TD 0232
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 8

Brief 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. 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

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

  12 months post-procedure

• 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.

  Within 30 days following procedure

Secondary Outcomes (9)

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

  12 months

• Secondary Endpoint of Acute Procedural Success Achieved in Number of Participants

  Day of Procedure

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

  6 months

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

  12 months

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

  6 months

Study Arms (1)

Lithoplasty Treatment

EXPERIMENTAL

Shockwave Lithoplasty System

Device: Shockwave Lithoplasty System

Interventions

Shockwave Lithoplasty System DEVICE

Lithoplasty Treatment

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (8)

Universitätsklinikum LKH Graz

Graz, Austria

Location

Hanusch Krankenhaus

Vienna, Austria

Location

Medizinische Universitat Wien

Vienna, Austria

Location

Universitäts-Herzzentrum Freiburg & Bad Krozingen

Bad Krozingen, Germany

Location

University Leipzig Medical Centre

Leipzig, Germany

Location

St. Franziskus Hospital

Münster, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, Germany

Location

Auckland City Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Gheda Sahyun, Director of Clinical Affairs
• Organization: Shockwave Medical, Inc.

gsahyun@shockwavemedical.com

510-624-9073

Study Officials

• Thomas Zeller, MD

  Universitäts-Herzzentrum Freiburg & Bad Krozingen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: February 9, 2015
• First Posted: February 24, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 18, 2018
• Results First Posted: April 18, 2018

Record last verified: 2018-03

Locations

NZ (1); DE (4); AU (3)