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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
480 Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT01403077
First received: July 25, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Superficial Femoral Artery Lesions
Atherosclerosis of Femoral Artery
Device: 480 Biomedical Bioresorbable Scaffold System

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Safety Assessment of the 480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo SFA Lesions

Resource links provided by NLM:


Further study details as provided by 480 Biomedical, Inc.:

Primary Outcome Measures:
  • Major adverse events at 6 months post procedure [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Major adverse events at 1 month post procedure [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]
  • Major adverse events at 3, 12 months and 24 months post procedure [ Time Frame: 3, 12 & 24 Months ] [ Designated as safety issue: Yes ]
  • Patency in the treated vessel at 1, 3, 6, 12 and 24 months post procedure [ Time Frame: 1, 3, 6, 12, 24 Months ] [ Designated as safety issue: No ]
  • Change in Rutherford Becker Category at 1, 3, 6,12 and 24 months post procedure [ Time Frame: 1, 3, 6, 12, 24 Months ] [ Designated as safety issue: No ]
  • Walking Impairment Questionnaire [ Time Frame: 1, 3, 6, 12, 24 Months ] [ Designated as safety issue: No ]
  • Ankle-Brachial Index (ABI) at 1, 3, 6, 12, and 24 months post procedure [ Time Frame: 1, 3, 6, 12, 24 Months ] [ Designated as safety issue: No ]
  • Clinically driven TLR at 3, 12 and 24 months post procedure [ Time Frame: 3,12, 24 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Scaffold Treatment Device: 480 Biomedical Bioresorbable Scaffold System
480 Biomedical Bioresorbable Scaffold System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403077

Locations
Australia
The Alfred
Melbourne, Australia
Austria
Universitäts Klinikum Graz
Graz, Austria
Germany
Universitaet Freiburg-Bad Krozingen
Freiburg, Germany
Park Hospital - Heart Center Leipzig
Leipzig, Germany
RoMed Klinikum Rosenheim
Rosenheim, Germany
New Zealand
Auckland City Hospital
Auckland, New Zealand
Sponsors and Collaborators
480 Biomedical, Inc.
  More Information

No publications provided

Responsible Party: 480 Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT01403077     History of Changes
Other Study ID Numbers: AVI-SFA2011-01
Study First Received: July 25, 2011
Last Updated: March 24, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by 480 Biomedical, Inc.:
Superficial femoral artery
Peripheral arterial disease
Atherosclerosis
Intermittent Claudication
Vascular Diseases
Cardiovascular Diseases

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014