Remedy, Biodegradable Peripheral Stent Registry

This study is currently recruiting participants.
Verified March 2013 by be Medical
Sponsor:
Information provided by:
be Medical
ClinicalTrials.gov Identifier:
NCT01420120
First received: August 16, 2011
Last updated: March 20, 2013
Last verified: March 2013

August 16, 2011
March 20, 2013
January 2011
June 2014   (final data collection date for primary outcome measure)
Absence of clinically driven target lesion revascularization at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01420120 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
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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.

Not Provided
Observational
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2014
June 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.
Both
18 Years and older
No
Not Provided
Belgium
 
NCT01420120
BM-REM-03-003
No
Joris Coteur, study coordinator, .be medical
be Medical
Not Provided
Not Provided
be Medical
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP