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

July 25, 2011
March 24, 2014
October 2011
July 2014   (final data collection date for primary outcome measure)
Major adverse events at 6 months post procedure [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
Major adverse events at 6 months post procedure [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Major adverse events at 6 months post procedure comprising:

  • Loss of patency defined as duplex ultrasound as PSVR > 2.4 which mandates a arteriogram
  • Thrombosis of target lesion
  • Target limb ischemia requiring surgical intervention (bypass, or amputation of toe, foot, leg below the knee, thigh)
  • Death
Complete list of historical versions of study NCT01403077 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Major adverse events at 1 month post procedure [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]

    Major adverse events at 1 month post procedure comprising:

    • Emergent interventional or surgical intervention on the target limb
    • Unplanned amputation
    • Myocardial infarction
    • Acute renal insufficiency
    • Death
  • Major adverse events at 3, 12 months and 24 months post procedure [ Time Frame: 3, 12 & 24 Months ] [ Designated as safety issue: Yes ]

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

    • Clinically Driven Target Lesion Revascularization (TLR) defined as symptomatic patients with:

      • Decrease in ABI > 0.15 and
      • Increase in Rutherford Becker Category > 1 and
      • >50% stenosis
    • Target limb ischemia requiring surgical intervention (bypass, or amputation of toe, foot, leg below the knee, thigh)
    • Worsening of Rutherford Becker Category by > 2 (or increase from 5 to 6)
  • Patency (PSVR ≤ 2.4 measured by duplex ultrasound) in the treated vessel at 1, 3, 6 and 12 months post procedure [ Time Frame: 1, 3, 6, 12 Months ] [ Designated as safety issue: No ]
    Patency (PSVR ≤ 2.4 measured by duplex ultrasound) in the treated vessel at 1, 3, 6 and 12 months post procedure
  • Change in Rutherford Becker Category at 1, 3, 6, and 12 months post procedure [ Time Frame: 1, 3, 6, 12 Months ] [ Designated as safety issue: No ]
    Change in Rutherford Becker Category at 1, 3, 6, and 12 months post procedure
  • Walking Impairement Questionnaire [ Time Frame: 1, 3, 6, 12 Months ] [ Designated as safety issue: No ]
    WIQ at 1, 3, 6, and 12 months post procedure
  • Ankle-Brachial Index (ABI) at 1, 3, 6, and 12 months post procedure [ Time Frame: 1, 3, 6, 12 Months ] [ Designated as safety issue: No ]
    Ankle-Brachial Index (ABI) at 1, 3, 6, and 12 months post procedure
  • Clinically driven TLR at 6 and 12 months post procedure [ Time Frame: 6 & 12 Months ] [ Designated as safety issue: No ]
    Clinically driven TLR at 6 and 12 months post procedure
Not Provided
Not Provided
 
480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo Superficial Femoral Artery (SFA) Lesions
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Superficial Femoral Artery Lesions
  • Atherosclerosis of Femoral Artery
Device: 480 Biomedical Bioresorbable Scaffold System
480 Biomedical Bioresorbable Scaffold System
Experimental: Scaffold Treatment
Intervention: Device: 480 Biomedical Bioresorbable Scaffold System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
September 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
New Zealand,   Germany,   Australia,   Austria
 
NCT01403077
AVI-SFA2011-01
Yes
480 Biomedical, Inc.
480 Biomedical, Inc.
Not Provided
Not Provided
480 Biomedical, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP