Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis (SHIELD)
|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: NCT02568293|
Recruitment Status : Active, not recruiting
First Posted : October 5, 2015
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Other: SBCV Other: Saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Multicenter, Parallel, Blinded, Randomized Comparison of the Safety and Efficacy of Balloon Angioplasty Plus Intraluminal SBCV To Balloon Angioplasty Alone for Treatment of Stenosis or Occlusion Within the Femoropopliteal Artery|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||October 2017|
SBCV is administered to the site immediately post balloon dilation.
SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.
Placebo Comparator: Control
Saline is used as a control and is delivered immediately post balloon dilation.
Saline is used as a control.
- Incidence of treatment-emergent adverse events [ Time Frame: through 24 weeks ]
The composite of no all-cause perioperative (≤30 day) mortality and none of the following events at 24 weeks following treatment:
- Index limb amputation (above or below the ankle)
- Index limb re-intervention
- Index-limb-related death
- Late Lumen Loss [ Time Frame: 24 weeks ]LLL is defined as the difference between the minimum lumen diameter (MLD) immediately post-primary procedure and the MLD at follow-up as measured by an independent, blinded core lab.
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): NCT02568293
|Australia, New South Wales|
|Royal Prince Alfred Hospital|
|Melbourne, New South Wales, Australia, 2050|
|Royal North Shore Hospital|
|Sydney, New South Wales, Australia, 2065|
|Gold Coast University Hospital|
|Southport, Queensland, Australia, 4215|
|Australia, South Australia|
|Flinders Medical Center|
|Adelaide, South Australia, Australia, 5043|
|Heidelberg, Victoria, Australia, 3084|
|The Alfred Hospital|
|Melbourne, Victoria, Australia, 3181|
|Australia, Western Australia|
|Sir Charles Gairdner Hospital|
|Perth, Western Australia, Australia, 6009|
|Auckland City Hospital|
|Auckland, New Zealand, 1023|