Remedy, Biodegradable Peripheral Stent Registry

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

Study Description

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.

Condition or disease
Peripheral Arterial Disease

Study Design

• 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

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Absence of clinically driven target lesion revascularization at 12 months. [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. 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.
2. Clinical success [ Time Frame: During procedure ]
   Defined as technical success without the occurrence of serious adverse events during procedure
3. Primary and secondary patency rate [ Time Frame: 12 months ]
   defined as < 50% diameter reduction and peak systolic velocity < 2.4 at 12 months.
4. Ankle-Brachial Index improvement of ≥ 0.1 [ Time Frame: 1, 6 and 12 months ]
5. Clinically driven target vessel revascularization [ Time Frame: 6 and 12 months ]
6. 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 ]
7. Rutherford-Becker classification of chronic limb ischemia [ Time Frame: 1, 6 and 12 months ]

Eligibility Criteria

• 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

Study Population

Patients with documented symptomatic occlusion and/or > 70% stenosis of SFA.

Criteria

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.

Contacts and Locations

Locations

Belgium

University Hospital Ghent

Ghent, Belgium

Sponsors and Collaborators

be Medical

More Information

• 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
• Last Update Posted: July 16, 2015
• Last Verified: July 2015

Keywords provided by be Medical:

Biodegradable stent, PAD

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases