Back to resultsSafety and Feasibility Study of the Shockwave Lithoplasty System
Primary Purpose
Vascular Disease
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Shockwave System Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Disease
Eligibility 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.
Sites / Locations
- Auckland City Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lithotripsy Treatment
Arm Description
Shockwave System Treatment -Lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Angiographic Success as measured by residual stenosis <30% reference vessel.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01577888
Brief Title
Safety and Feasibility Study of the Shockwave Lithoplasty System
Official Title
Safety and Feasibility Study of the Shockwave Lithoplasty System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shockwave Medical, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lithotripsy Treatment
Arm Type
Experimental
Arm Description
Shockwave System Treatment -Lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries.
Intervention Type
Device
Intervention Name(s)
Shockwave System Treatment
Intervention Description
Shockwave System Treatment during vascular disease intervention.
Primary Outcome Measure Information:
Title
Safety determined by 30day New-Onset Serious Adverse Events
Description
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.
Time Frame
30 day
Secondary Outcome Measure Information:
Title
Angiographic Success as measured by residual stenosis <30% reference vessel.
Time Frame
Peri-Procedural
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Holden, MD
Organizational Affiliation
Auckland City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
92024
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
Safety and Feasibility Study of the Shockwave Lithoplasty System
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