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

A Safety Assessment of the 480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo SFA Lesions

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis of Femoral Artery; Superficial Femoral Artery Lesions
• Intervention / Treatment: Device: 480 Biomedical Bioresorbable Scaffold System

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • The Alfred
• Austria
  • Graz, Austria
    • Universitäts Klinikum Graz
• Germany
  • Freiburg, Germany
    • Universitaet Freiburg-Bad Krozingen
  • Leipzig, Germany
    • Park Hospital - Heart Center Leipzig
  • Rosenheim, Germany
    • RoMed Klinikum Rosenheim
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age >/= 18 years
2. 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
3. Lifestyle-limiting claudication defined as symptomatic subjects with Rutherford Becker Category 2-3
4. 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%
5. Lesion length: up to a maximum that can be covered by one 100mm scaffold
6. Target lesion > 50% stenosis or total occlusion
7. 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
8. Patent common and external iliac; TASC A & B lesions may be successfully treated (<30% residual stenosis) at the time of the index procedure
9. 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
10. The study patient agrees to comply with all required post-procedure follow-up visits

Exclusion Criteria:

1. Previously implanted stent(s) or stent graft(s) in the target lesion
2. Previous endovascular treatment of the target lesion
3. Femoral access in the target limb within 30 days of study procedure
4. Target lesion residual stenosis > 30% after pre-dilatation with nominally sized balloon
5. Severely calcified lesions as determined by a balloon deformity during dilatation with a nominally sized balloon inflated at nominal pressure.
6. Acute embolic complication at the trifurcation following pre-dilatation not resolved by aspiration
7. Target vessel contains acute thrombus
8. Aneurysm in target vessel
9. Critical limb ischemia defined as Rutherford-Becker Category 4-6
10. Intolerance, or allergies which cannot be adequately pre-medicated, to the following: aspirin, clopidogrel or ticlopidine, heparin, any scaffold components, contrast agents
11. Life expectancy of less than 12 months
12. Pregnancy or breast feeding (negative pregnancy test within 7 days required in females of child bearing potential)
13. Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease)
14. Renal insufficiency (serum creatinine level > 220 µmol/L, or subject is on dialysis)
15. Immunocompromised
16. Active systemic infection or lower limb infection of any nature
17. WBC < 3,000 cells/mm3
18. Myocardial infarction within the past 1 month
19. Stroke within 3 months
20. Un-controlled Atrial-Fibrillation
21. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Scaffold Treatment	Device: 480 Biomedical Bioresorbable Scaffold System; 480 Biomedical Bioresorbable Scaffold System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major adverse events at 6 months post procedure	6 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Ankle-Brachial Index (ABI) at 1, 3, 6, 12, and 24 months post procedure	1, 3, 6, 12, 24 Months
Clinically driven TLR at 3, 12 and 24 months post procedure	3,12, 24 Months

Collaborators and Investigators

• Sponsor: 480 Biomedical

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (ESTIMATE): July 27, 2011

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Intermittent Claudication; Superficial femoral artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: AVI-SFA2011-01