Remedy, Biodegradable Peripheral Stent Registry
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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: NCT01420120 |
Recruitment Status :
Completed
First Posted : August 19, 2011
Last Update Posted : July 16, 2015
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Condition or disease |
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Peripheral Arterial Disease |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | A Prospective Multicenter Registry to Evaluate Safety and Performance of REMEDY, Biodegradable Peripheral Stent for the Treatment of Occluded or Stenotic Superficial Femoral Arteries. |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |
- Absence of clinically driven target lesion revascularization at 12 months. [ Time Frame: 12 months ]
- Technical success [ Time Frame: During procedure ]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 ]Defined as technical success without the occurrence of serious adverse events during procedure
- Primary and secondary patency rate [ Time Frame: 12 months ]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 ]
- Clinically driven target vessel revascularization [ Time Frame: 6 and 12 months ]
- 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 ]
- Rutherford-Becker classification of chronic limb ischemia [ Time Frame: 1, 6 and 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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Patients with symptomatic leg ischemia requiring treatment of SFA artery or proximal popliteal artery located within the following parameters:
- 1 cm from the femoral bifurcation in the SFA
- 3 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.
Exclusion Criteria:
- Pregnancy
- 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.

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): NCT01420120
Belgium | |
University Hospital Ghent | |
Ghent, Belgium |
Responsible Party: | Joris Coteur, study coordinator, .be medical |
ClinicalTrials.gov Identifier: | NCT01420120 |
Other Study ID Numbers: |
BM-REM-03-003 |
First Posted: | August 19, 2011 Key Record Dates |
Last Update Posted: | July 16, 2015 |
Last Verified: | July 2015 |
Biodegradable stent, PAD |
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |