Safety and Feasibility Study of the Shockwave Lithoplasty System

NCT01577888 | Completed DMC

• 1 other identifier: TD-0047
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

To study the early safety and performance of the Shockwave Medical System in subjects to demonstrate that the device can safely and effectively deliver localized energy for the treatment of vascular disease.

Conditions

Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Safety determined by 30day New-Onset Serious Adverse Events

  New Onset Serious Adverse Events (SAE) include death, device-related surgery or repeat hospitalization, occlusion, or major unplanned amputation through 30 days following the procedure.

  30 day

Secondary Outcomes (1)

• Angiographic Success as measured by residual stenosis <30% reference vessel.

  Peri-Procedural

Study Arms (1)

Lithotripsy Treatment

EXPERIMENTAL

Shockwave System Treatment -Lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries.

Device: Shockwave System Treatment

Interventions

Shockwave System Treatment DEVICE

Shockwave System Treatment during vascular disease intervention.

Lithotripsy Treatment

Eligibility Criteria

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

You may qualify if:

• Age \>18
• Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
• Female subjects of childbearing potential have a negative pregnancy test less than 7 days before the procedure.
• Patient is able and willing to comply with all assessments in the study.
• Peripheral arterial disease of Rutherford Category 2, 3, 4, and 5.
• Ability to tolerate an antiplatelet agent (i.e. aspirin, clopidigrel or prasagrel).

You may not qualify if:

• Patients with peripheral arterial disease of Rutherford Category 6.
• Severe or infected gangrene of the lower extremity.
• Planned major amputation.
• Previously implanted stent at the treatment site.
• Patient with an externally-connected intracardiac catheter or pacemaker.
• Patient with an implantable pacemaker or defibrillator.
• Patient has connective tissue disease (e.g., Marfan's syndrome).
• Patient has a hypercoagulable disorder.
• Patient has allergy to imaging contrast media for which they cannot be premedicated.
• Patient is in acute renal failure or chronic renal insufficiency or failure as measured by a serum creatinine of \>19.5 µmol/L.
• Patient has active systemic infection.
• Patient has less than a one year life expectancy.
• Patient is pregnant or nursing.
• Patient is participating in another research study involving an investigational agent that has not reached the primary endpoint.
• Patient 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.

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (1)

Auckland City Hospital

Auckland, 92024, New Zealand

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Andrew Holden, MD

  Auckland City Hospital

  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: April 11, 2012
• First Posted: April 16, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 8, 2014

Record last verified: 2014-08

Locations

NZ (1)