Remedy, Biodegradable Peripheral Stent Registry
This study is currently recruiting participants.
Verified March 2013 by be Medical
Information provided by:
First received: August 16, 2011
Last updated: March 20, 2013
Last verified: March 2013
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.
Peripheral Arterial Disease
||Observational Model: Case-Only
Time Perspective: Prospective
||A Prospective Multicenter Registry to Evaluate Safety and Performance of REMEDY, Biodegradable Peripheral Stent for the Treatment of Occluded or Stenotic Superficial Femoral Arteries.
Primary Outcome Measures:
- Absence of clinically driven target lesion revascularization at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Technical success [ Time Frame: During procedure ] [ Designated as safety issue: No ]
Defined as a successful access and deployment of the device and determined by less than 30% residual stenosis by angiography at the baseline procedure.
- Clinical success [ Time Frame: During procedure ] [ Designated as safety issue: Yes ]
Defined as technical success without the occurrence of serious adverse events during procedure
- Primary and secondary patency rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
defined as < 50% diameter reduction and peak systolic velocity < 2.4 at 12 months.
- Ankle-Brachial Index improvement of ≥ 0.1 [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: No ]
- Clinically driven target vessel revascularization [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Major complications at 6 and 12 months, including amputation of a part of the foot, the leg below and above the knee. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Rutherford-Becker classification of chronic limb ischemia [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with documented symptomatic occlusion and/or > 70% stenosis of SFA.
- Previous stenting of target lesion
- Acute ischemia
- Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion). Inclusion of a patient is allowed in case inflow lesions are successfully treated during the index-procedure yielding less than 30% diameter stenosis.
- Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
- Known intolerance to study medications or contrast agents.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420120
No publications provided
||Joris Coteur, study coordinator, .be medical
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 16, 2011
||March 20, 2013
||Belgium: Ethics Committee
Keywords provided by be Medical:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases