Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis

NCT02911623 | Completed

• 1 other identifier: TD 0258
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 4

Brief Summary

To observe early safety and performance of the Shockwave Medical Lithoplasty® System (specifically, Lithoplasty® Catheters: 2.5 x 60mm, 2.75 x 60mm, 3.0 x 60mm, 3.25 x 60mm, and 3.5 x 60mm) in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized pulsatile mechanical energy for balloon dilation of calcified, stenotic, infrapopliteal arteries.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Composite of new-onset Major Adverse Events (MAE)

  Death Myocardial infarction Need for emergency surgical revascularization of the target limb. Amputation of target limb.

  Procedure through 30 days post procedure

• Efficacy

  Acute reduction in percent (%) diameter stenosis of target lesion

  Peri-Procedural

Secondary Outcomes (1)

• Procedural Success

  Peri-Procedural

Study Arms (1)

Lithoplasty Treatment

EXPERIMENTAL

Patients in this group will receive treatment with the Shockwave Lithoplasty® System which uses lithotripsy-enhanced, low-pressure balloon dilation of calcified stenotic peripheral arteries.

Device: Shockwave Lithoplasty® System

Interventions

Shockwave Lithoplasty® System DEVICE

The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator.

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 1 - 5.
• Single or multiple target lesion(s) is/are located in a de novo artery distal to the trifurcation vessels and extends to and ends above the ankle
• Target vessel reference diameter is between 2.5mm and 3.5mm by visual estimate
• Target lesion with diameter stenosis ≥50% by investigator via visual estimate
• If inflow disease \>50% proximal to the trifurcation vessels is present, and it can be treated with POBA, stent or Lithoplasty and without complications.
• Target lesion is ≤150mm in length
• Subject has at least one patent tibial vessel (\>50%) with run-off to the foot.
• No evidence of aneurysm or acute thrombus in target vessel.
• Any presence of calcification within the target lesion as assessed by imaging (radiograph, CT or angiography).

You may not qualify if:

• Rutherford Clinical Category 6.
• Target lesion is within only lower extremity vessel with \< 50% stenosis.
• Gangrene of the lower extremity.
• Planned major amputation of the target leg.
• Previously implanted stent in the treatment lesion
• Target lesion length exceeds 150mm.
• Patient has chronic total occlusion of target lesion.
• Patient has significant stenosis (\>50% stenosis) or occlusion of inflow tract (e.g., iliac or common femoral) not successfully treated with POBA, stent or Lithoplasty and without complications.
• Patient in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
• Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• Patient has known allergy to urethane, nylon, or silicone.
• Patient is pregnant or nursing.
• Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (4)

Medizinische Universitaet Graz

Graz, 8036, Austria

Location

Hanusch Krankenhaus

Vienna, Austria

Location

Department of Angiology - Universitats Herzzentrum Freiburg

Bad Krozingen, Baden-Wurttemberg, 79189, Germany

Location

Auckland City Hospital

Auckland, New Zealand

Location

Related Publications (1)

• Brodmann M, Holden A, Zeller T. Safety and Feasibility of Intravascular Lithotripsy for Treatment of Below-the-Knee Arterial Stenoses. J Endovasc Ther. 2018 Aug;25(4):499-503. doi: 10.1177/1526602818783989. Epub 2018 Jun 18.

  PMID: 29911480 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Marianne Brodmann, MD

  Universitätsklinikum LKH Graz

  PRINCIPAL INVESTIGATOR

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: September 16, 2016
• First Posted: September 22, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-10

Locations

NZ (1); DE (1); AU (2)