Safety and Performance Study of the Shockwave Lithoplasty System

NCT02071108 | Completed Results DMC

• 1 other identifier: TD 0083
• Study Type: interventional
• Target: 35
• Locations: 3 countries
• Sites: 3

Brief Summary

To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, infrainguinal peripheral arteries.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

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

  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 or noted angiographically, and requiring mechanical or pharmacologic means to improve flow. Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting.

  30 days

• Procedural Success:

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

  Day of Procedure

Secondary Outcomes (13)

• Device Success

  Day of Procedure

• Clinical Success:

  Day of Procedure

• Technical Success:

  Day of Procedure

• Freedom From Major Adverse Events

  30 days

• Freedom From Target Lesion Revascularization (TLR)

  30 days

Other Outcomes (1)

• Exploratory Endpoint

  Day of Procedure

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.
• Moderate to severe calcification of target lesion(s) per pre-procedure CT scan. (Calcification must be: 1) ≥180 degrees circumferential at some point in the lesion and 2) extend ≥50 percent length of lesion or absolute length ≥20mm.)
• Estimated life expectancy \>1 year.

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).
• In-stent restenosis within the target lesion(s).
• Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
• Chronic total occlusion of the target lesion(s).
• Target lesion(s) within native or synthetic vessel grafts.
• Chronic total occlusion of inflow vessel.
• Lesion in contralateral limb requiring intervention within the next 30 days.
• 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 (upstream disease) not successfully treated with plain old balloon angioplasty or stent and without complications before target lesion(s) treatment.
• Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target lesion(s) 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 \>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 (3)

Medizinische Universitaet Graz

Graz, Graz, 8036, Austria

Location

Department of Angiology - Universitats Herzzentrum Freiburg

Bad Krozingen, Baden-Wurttemberg, 79189, Germany

Location

Auckland City Hospital

Auckland, Auckland, 92024, 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

  Bad Krozingen

  PRINCIPAL INVESTIGATOR

• Andrew Holden, MD

  Auckland City Hospital

  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 22, 2014
• First Posted: February 25, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: March 1, 2015
• Last Updated: March 24, 2017
• Results First Posted: October 11, 2016

Record last verified: 2017-02

Locations

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