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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absence of clinically driven target lesion revascularization at 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Defined as a successful access and deployment of the device and determined by less than 30% residual stenosis by angiography at the baseline procedure.	During procedure
Clinical success	Defined as technical success without the occurrence of serious adverse events during procedure	During procedure
Primary and secondary patency rate	defined as < 50% diameter reduction and peak systolic velocity < 2.4 at 12 months.	12 months
Ankle-Brachial Index improvement of ≥ 0.1		1, 6 and 12 months
Clinically driven target vessel revascularization		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.		6 and 12 months
Rutherford-Becker classification of chronic limb ischemia		1, 6 and 12 months

Collaborators and Investigators

• Sponsor: be Medical

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: August 16, 2011
• First Submitted That Met QC Criteria: August 18, 2011
• First Posted (Estimate): August 19, 2011

Study Record Updates

• Last Update Posted (Estimate): July 16, 2015
• Last Update Submitted That Met QC Criteria: July 15, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Biodegradable stent, PAD
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: BM-REM-03-003