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
|Condition or disease||Intervention/treatment||Phase|
|Vascular Disease||Device: Shockwave System Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Feasibility Study of the Shockwave Lithoplasty System|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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.
- 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.
- Angiographic Success as measured by residual stenosis <30% reference vessel. [ Time Frame: Peri-Procedural ]
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
|Auckland City Hospital|
|Auckland, New Zealand, 92024|
|Principal Investigator:||Andrew Holden, MD||Auckland City Hospital|