Remedy, Biodegradable Peripheral Stent Registry
A Prospective Multicenter Registry to Evaluate Safety and Performance of REMEDY, Biodegradable Peripheral Stent for the Treatment of Occluded or Stenotic Superficial Femoral Arteries.
1 other identifier
observational
100
1 country
1
Brief Summary
This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries. Patients will be followed for a period of 1 year.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 16, 2011
CompletedFirst Posted
Study publicly available on registry
August 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedJuly 16, 2015
July 1, 2015
3.7 years
August 16, 2011
July 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absence of clinically driven target lesion revascularization at 12 months.
12 months
Secondary Outcomes (7)
Technical success
During procedure
Clinical success
During procedure
Primary and secondary patency rate
12 months
Ankle-Brachial Index improvement of ≥ 0.1
1, 6 and 12 months
Clinically driven target vessel revascularization
6 and 12 months
- +2 more secondary outcomes
Eligibility Criteria
Patients with documented symptomatic occlusion and/or \> 70% stenosis of SFA.
You may qualify if:
- Patients with symptomatic leg ischemia requiring treatment of SFA artery or proximal popliteal artery located within the following parameters:
- cm from the femoral bifurcation in the SFA
- cm from the proximal margin of the intercondylar fossa
- Rutherford-Becker Category 2-5. In patients with bilateral lesions, the highest Rutherford Category limb should be treated. Only 1 leg can be included.
- Single lesion which can be covered by one stent.
- Target vessel reference diameter ≥ 4 mm and ≤ 6 mm (by visual estimate)
- A patent popliteal artery free from significant stenosis (\>50%) with at least one patent vessel runoff as confirmed by baseline angiography
- Signed informed consent.
You may not qualify if:
- Pregnancy
- Previous stenting of target lesion
- Acute ischemia
- Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
- Known intolerance to study medications or contrast agents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- be Medicallead
Study Sites (1)
University Hospital Ghent
Ghent, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 16, 2011
First Posted
August 19, 2011
Study Start
January 1, 2011
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
July 16, 2015
Record last verified: 2015-07