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Safety and Feasibility Study of the Shockwave Lithoplasty System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01577888
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Vascular Disease Device: Shockwave System Treatment

Detailed Description:
Shockwave Medical, Inc. intends to conduct a prospective, single-arm, single-center, First in Human study designed to evaluate the early safety and feasibility of the Shockwave Lithoplasty System in subjects with heavily calcified infrainguinal arteries with 3.75mm to 6mm reference vessel diameter at 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 10 subjects will be enrolled to undergo lihtoplasty.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility Study of the Shockwave Lithoplasty System
Study Start Date : August 2012
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lithotripsy Treatment
Shockwave System Treatment -Lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries.
Device: Shockwave System Treatment
Shockwave System Treatment during vascular disease intervention.


Outcome Measures

Primary Outcome Measures :
  1. Safety determined by 30day New-Onset Serious Adverse Events [ Time Frame: 30 day ]
    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.


Secondary Outcome Measures :
  1. Angiographic Success as measured by residual stenosis <30% reference vessel. [ Time Frame: Peri-Procedural ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).
  • Meets Angiographic Inclusion Criteria

Exclusion Criteria:

  • 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.
  • Chronic total occlusion of target vessel.
  • Chronic total occlusion of inflow vessel.
  • Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon)
  • Patients requiring concurrent intervention below the most distal target lesion.
  • Inflow disease: Stenosis of >50% in vessel proximal to the target lesion which requires treatment with Drug Eluting Balloon (DEB) or atherectomy.
  • Prior procedure in target leg within past 3 months.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577888


Locations
New Zealand
Auckland City Hospital
Auckland, New Zealand, 92024
Sponsors and Collaborators
Shockwave Medical, Inc.
Investigators
Principal Investigator: Andrew Holden, MD Auckland City Hospital
More Information

Responsible Party: Shockwave Medical, Inc.
ClinicalTrials.gov Identifier: NCT01577888     History of Changes
Other Study ID Numbers: TD-0047
First Posted: April 16, 2012    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases