480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo Superficial Femoral Artery (SFA) Lesions

NCT01403077 | Completed DMC

• 1 other identifier: AVI-SFA2011-01
• Study Type: interventional
• Target: 46
• Locations: 3 countries
• Sites: 5

Brief Summary

This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the treatment of subjects with de novo native superficial femoral artery lesions.

Conditions

Superficial Femoral Artery Lesions; Atherosclerosis of Femoral Artery

Keywords

Superficial femoral artery; Peripheral arterial disease; Atherosclerosis; Intermittent Claudication; Vascular Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Major adverse events at 6 months post procedure

  6 Months

Secondary Outcomes (7)

• Major adverse events at 1 month post procedure

  1 Month

• Major adverse events at 3, 12 months and 24 months post procedure

  3, 12 & 24 Months

• Patency in the treated vessel at 1, 3, 6, 12 and 24 months post procedure

  1, 3, 6, 12, 24 Months

• Change in Rutherford Becker Category at 1, 3, 6,12 and 24 months post procedure

  1, 3, 6, 12, 24 Months

• Walking Impairment Questionnaire

  1, 3, 6, 12, 24 Months

Study Arms (1)

Scaffold Treatment

EXPERIMENTAL

Device: 480 Biomedical Bioresorbable Scaffold System

Interventions

480 Biomedical Bioresorbable Scaffold System DEVICE

480 Biomedical Bioresorbable Scaffold System

Scaffold Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/= 18 years
• De novo stenotic lesion(s) in the superficial femoral artery located at least 1cm distal to the femoral bifurcation and \> 3 cm above the knee joint
• Lifestyle-limiting claudication defined as symptomatic subjects with Rutherford Becker Category 2-3
• Target lesion native reference vessel diameter 4.6 - 6.0 mm by on-line QVA; target lesion native reference vessel diameter less than 5.0 mm only if lesion residual stenosis is ≤ 25%
• Lesion length: up to a maximum that can be covered by one 100mm scaffold
• Target lesion \> 50% stenosis or total occlusion
• Undisturbed flow to the foot via at least 2 patent infrapopliteal vessel on the treated side with one vessel free from \> 50% stenosis to the ankle joint
• Patent common and external iliac; TASC A \& B lesions may be successfully treated (\<30% residual stenosis) at the time of the index procedure
• The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Human Research Ethics Committee (HREC) of the respective clinical site
• The study patient agrees to comply with all required post-procedure follow-up visits

You may not qualify if:

• Previously implanted stent(s) or stent graft(s) in the target lesion
• Previous endovascular treatment of the target lesion
• Femoral access in the target limb within 30 days of study procedure
• Target lesion residual stenosis \> 30% after pre-dilatation with nominally sized balloon
• Severely calcified lesions as determined by a balloon deformity during dilatation with a nominally sized balloon inflated at nominal pressure.
• Acute embolic complication at the trifurcation following pre-dilatation not resolved by aspiration
• Target vessel contains acute thrombus
• Aneurysm in target vessel
• Critical limb ischemia defined as Rutherford-Becker Category 4-6
• Intolerance, or allergies which cannot be adequately pre-medicated, to the following: aspirin, clopidogrel or ticlopidine, heparin, any scaffold components, contrast agents
• Life expectancy of less than 12 months
• Pregnancy or breast feeding (negative pregnancy test within 7 days required in females of child bearing potential)
• Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease)
• Renal insufficiency (serum creatinine level \> 220 µmol/L, or subject is on dialysis)
• Immunocompromised

Sponsors & Collaborators

• 480 Biomedical: lead

Study Sites (6)

The Alfred

Melbourne, Australia

Location

Universitäts Klinikum Graz

Graz, Austria

Location

Universitaet Freiburg-Bad Krozingen

Freiburg im Breisgau, Germany

Location

Park Hospital - Heart Center Leipzig

Leipzig, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, Germany

Location

Auckland City Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis; Intermittent Claudication; Vascular Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 27, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: October 1, 2015
• Last Updated: September 6, 2019

Record last verified: 2016-02

Locations

AU (1); NZ (1); DE (3)