- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01577888
Safety and Feasibility Study of the Shockwave Lithoplasty System
August 6, 2014 updated by: Shockwave Medical, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / 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 Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Auckland, New Zealand, 92024
- Auckland City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lithotripsy Treatment
Shockwave System Treatment -Lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries.
|
Shockwave System Treatment during vascular disease intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Angiographic Success as measured by residual stenosis <30% reference vessel.
Time Frame: Peri-Procedural
|
Peri-Procedural
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Holden, MD, Auckland City Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
April 11, 2012
First Submitted That Met QC Criteria
April 13, 2012
First Posted (Estimate)
April 16, 2012
Study Record Updates
Last Update Posted (Estimate)
August 8, 2014
Last Update Submitted That Met QC Criteria
August 6, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TD-0047
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vascular Disease
-
Stanford UniversityTerminatedPAD - Peripheral Arterial Disease | PVD- Peripheral Vascular DiseaseUnited States
-
Baylor UniversityNational Institute on Aging (NIA)RecruitingArterial Occlusive Diseases | Peripheral Arterial Disease | Atherosclerosis | Vascular Diseases, PeripheralUnited States
-
C. R. BardCromsourceCompletedVascular Diseases, PeripheralGermany, Poland
-
Horizons International Peripheral GroupAdvanced Catheter Therapies, Inc.CompletedCardiovascular Disease | Peripheral Arterial Disease | Peripheral Vascular DiseaseUnited States
-
Abbott Medical DevicesCompletedCardiovascular Disease | Peripheral Vascular DiseaseUnited States
-
Unity Health TorontoUnknownPeripheral Vascular Disease Patient
-
Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI)Not yet recruitingPeripheral Vascular Disease | Peripheral Artery DiseaseUnited States
-
C. R. BardCompletedArterial Occlusive Diseases | Peripheral Arterial Disease | Peripheral Vascular DiseasesUnited States
-
University of MichiganTerminatedPeripheral Vascular Disease | Peripheral Artery DiseaseUnited States
-
SensomeRecruitingPeripheral Vascular DiseaseBelgium
Clinical Trials on Shockwave System Treatment
-
InitiaCompletedVasculogenic Erectile DysfunctionIsrael
-
Cynosure, Inc.CompletedConnective Tissue DefectUnited States
-
Maastricht University Medical CenterMedispec ltd.Unknown
-
Rambam Health Care CampusCompletedProvoked VestibulodyniaIsrael
-
The Cleveland ClinicRecruitingErectile Dysfunction | Chronic Prostatitis | Chronic Pelvic Pain Syndrome | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Erectile Dysfunction Due to Arterial Insufficiency | Erectile Dysfunction Due to Arterial DiseaseUnited States
-
SoftWave Tissue Regeneration TechnologiesRecruitingFemale DyspareuniaUnited States
-
Taif UniversityRecruitingAdhesive Capsulitis of ShoulderSaudi Arabia
-
Riphah International UniversityCompletedAdhesive Capsulitis of ShoulderPakistan
-
InitiaTerminatedVasculogenic Erectile DysfunctionIsrael
-
Shockwave Medical, Inc.CompletedPeripheral Arterial DiseaseAustria, Germany, New Zealand