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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01403077
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Lyra Therapeutics ( 480 Biomedical )

Tracking Information
First Submitted Date  ICMJE July 25, 2011
First Posted Date  ICMJE July 27, 2011
Last Update Posted Date September 6, 2019
Study Start Date  ICMJE October 2011
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2011)
Major adverse events at 6 months post procedure [ Time Frame: 6 Months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
Major adverse events at 6 months post procedure [ Time Frame: 6 Months ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
  • Major adverse events at 1 month post procedure [ Time Frame: 1 Month ]
  • Major adverse events at 3, 12 months and 24 months post procedure [ Time Frame: 3, 12 & 24 Months ]
  • Patency in the treated vessel at 1, 3, 6, 12 and 24 months post procedure [ Time Frame: 1, 3, 6, 12, 24 Months ]
  • Change in Rutherford Becker Category at 1, 3, 6,12 and 24 months post procedure [ Time Frame: 1, 3, 6, 12, 24 Months ]
  • Walking Impairment Questionnaire [ Time Frame: 1, 3, 6, 12, 24 Months ]
  • Ankle-Brachial Index (ABI) at 1, 3, 6, 12, and 24 months post procedure [ Time Frame: 1, 3, 6, 12, 24 Months ]
  • Clinically driven TLR at 3, 12 and 24 months post procedure [ Time Frame: 3,12, 24 Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
  • Major adverse events at 1 month post procedure [ Time Frame: 1 Month ]
    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 ]
    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 ]
    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 ]
    Change in Rutherford Becker Category at 1, 3, 6, and 12 months post procedure
  • Walking Impairement Questionnaire [ Time Frame: 1, 3, 6, 12 Months ]
    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 ]
    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 ]
    Clinically driven TLR at 6 and 12 months post procedure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo Superficial Femoral Artery (SFA) Lesions
Official Title  ICMJE A Safety Assessment of the 480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo SFA Lesions
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Superficial Femoral Artery Lesions
  • Atherosclerosis of Femoral Artery
Intervention  ICMJE Device: 480 Biomedical Bioresorbable Scaffold System
480 Biomedical Bioresorbable Scaffold System
Study Arms  ICMJE Experimental: Scaffold Treatment
Intervention: Device: 480 Biomedical Bioresorbable Scaffold System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2016)
46
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2011)
60
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Germany,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01403077
Other Study ID Numbers  ICMJE AVI-SFA2011-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lyra Therapeutics ( 480 Biomedical )
Study Sponsor  ICMJE 480 Biomedical
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lyra Therapeutics
Verification Date February 2016

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