Remedy, Biodegradable Peripheral Stent Registry

Peripheral Arterial Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420120
• Other study ID #: BM-REM-03-003
• Status: Completed
• Phase: N/A
• First received: August 16, 2011
• Last updated: July 15, 2015
• Start date: January 2011
• Est. completion date: September 2014

Study information

• Verified date: July 2015
• Source: be Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
be Medical

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of clinically driven target lesion revascularization at 12 months.		12 months	No
Secondary	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	No
Secondary	Clinical success	Defined as technical success without the occurrence of serious adverse events during procedure	During procedure	Yes
Secondary	Primary and secondary patency rate	defined as < 50% diameter reduction and peak systolic velocity < 2.4 at 12 months.	12 months	No
Secondary	Ankle-Brachial Index improvement of = 0.1		1, 6 and 12 months	No
Secondary	Clinically driven target vessel revascularization		6 and 12 months	No
Secondary	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	No
Secondary	Rutherford-Becker classification of chronic limb ischemia		1, 6 and 12 months	No