Remedy, Biodegradable Peripheral Stent Registry

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. Identifier: NCT01420120
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : July 16, 2015
Information provided by:
be Medical

August 16, 2011
August 19, 2011
July 16, 2015
January 2011
September 2014   (Final data collection date for primary outcome measure)
Absence of clinically driven target lesion revascularization at 12 months. [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01420120 on Archive Site
  • 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 ]
Same as current
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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.
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.
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Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Patients with documented symptomatic occlusion and/or > 70% stenosis of SFA.
Peripheral Arterial Disease
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Joris Coteur, study coordinator, .be medical
be Medical
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be Medical
July 2015