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The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease

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: NCT03994185
Recruitment Status : Withdrawn (Study was withdrawn by the Sponsor prior to enrollment)
First Posted : June 21, 2019
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Merit Medical Systems, Inc.

Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date April 24, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Safety endpoint of subjects free from specified adverse events [ Time Frame: 4 weeks after placement of WRAPSODY stent graft ]
    The primary study safety endpoint is the proportion of subjects free from a composite of device- or procedure-related death, myocardial infarction, or amputation above the metatarsals in the treated leg resulting from a vascular event, or device- or procedure-related serious adverse events within 4 weeks of the index procedure.
  • Effectiveness endpoint of subjects with improvement of Rutherford Category [ Time Frame: 4 weeks after placement of WRAPSODY stent graft ]
    The primary clinical effectiveness endpoint is the proportion of subjects with improvement of at least 1 Rutherford category within 4 weeks of the index procedure. Composite with Outcome 3.
  • Effectiveness endpoint of subjects with patency [ Time Frame: 4 weeks after placement of WRAPSODY stent graft ]
    The primary clinical effectiveness endpoint is the proportion of subjects with patency as evaluated by duplex ultrasound at 4 weeks after index procedure. Composite with Outcome 2.
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Primary Safety Endpoint [ Time Frame: 4 weeks after placement of WRAPSODY stent graft ]
    The primary study safety endpoint is the proportion of subjects free from a composite of device- or procedure-related death, myocardial infarction, or amputation above the metatarsals in the treated leg resulting from a vascular event, or device- or procedure-related serious adverse events within 4 weeks of the index procedure.
  • Primary Efficacy Endpoint 1 [ Time Frame: 4 weeks after placement of WRAPSODY stent graft ]
    The primary clinical effectiveness endpoint is the proportion of subjects with improvement of at least 1 Rutherford category.
  • Primary Efficacy Endpoint 2 [ Time Frame: 4 weeks after placement of WRAPSODY stent graft ]
    The primary clinical effectiveness endpoint is the proportion of subjects with patency as evaluated by duplex ultrasound at 4 weeks after index procedure.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
Official Title  ICMJE Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
Brief Summary This is a prospective, single-center, non-randomized phase 2, first-in-iliac artery study, to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of peripheral arterial occlusive disease in symptomatic subjects with de novo or restenotic lesions in the common iliac artery (CIA) and/or external iliac artery (EIA), including lesions at the aortic bifurcation.
Detailed Description

Approximately 30 subjects will be enrolled. Post study procedure subjects will have planned follow-up visits at 4 weeks, 24, 36 and 52 weeks, and unscheduled visits as medically necessary,

The primary study safety endpoint is the proportion of subjects free from a composite of device- or procedure-related death, myocardial infarction, or amputation above the metatarsals in the treated leg resulting from a vascular event, or device- or procedure-related serious adverse events within 4 weeks of the index procedure. The primary clinical effectiveness endpoint is the proportion of subjects with a composite improvement of at least 1 Rutherford category and patency as evaluated by duplex ultrasound at 4 weeks after index procedure.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Approximately 30 subjects will be enrolled and treated with the study device
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stenosis of Artery
  • Peripheral Arterial Disease
  • Iliac Artery Disease
  • Iliac Artery Occlusion
Intervention  ICMJE Device: Placement of WRAPSODY stent graft
Placement of WRAPSODY stent graft into the iliac arteries and/or aortic bifurcation.
Study Arms  ICMJE Experimental: Group Treated with stent graft
This is a single arm study. All subjects will be treated with the WRAPSODY stent graft.
Intervention: Device: Placement of WRAPSODY stent graft
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 21, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2019)
30
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject has signed informed consent
  2. Subject is ≥ 21 years of age
  3. Subject is able and willing to comply with study requirements
  4. Male, infertile female, or female practicing contraception and a negative pregnancy test within 7 days prior to the study procedure
  5. Symptomatic claudication or rest pain without tissue loss, Rutherford category 2-4
  6. Angiographic evidence of de novo or restenotic target lesion(s) in native vessels in the common and/or external iliac artery(ies) (multiple stenoses may exist within the target lesion)
  7. Total lesion(s) length is ≤ 110mm
  8. Target lesion(s) is at least 3 cm from an existing stent or stent graft
  9. At least 1 stenosis in the target vessel has ≥ 50% stenosis
  10. Target vessel diameter is between 4.6 and 14.4mm at angiographic screening for device placement
  11. Adequate ipsilateral blood flow, including at least 1 patent (<50% stenotic) superficial femoral or profundal femoral artery
  12. Full expansion of an appropriately sized (in the investigator's opinion) standard angioplasty balloon has been achieved during primary angioplasty at the target lesion prior to enrollment

Exclusion Criteria:

  1. Subject has undergone an intervention (surgical or percutaneous) in the target limb(s) <30 days from the date of the index study procedure
  2. Subject has a surgical or percutaneous procedure in the target limb(s) planned within 30 days following the index study procedure
  3. Previous or planned bypass surgery in the target limb(s)
  4. Coronary intervention within 30 days prior to enrollment or planned within 12 months after index study procedure
  5. Subject has had a stroke within 90 days prior to the index study procedure
  6. Subject has had a transient ischemic attack within 30 days prior to the index study procedure
  7. Uncorrectable coagulation disorder
  8. Subject cannot receive heparin, dual antiplatelet treatment, or anticoagulant(s) appropriate in the opinion of the investigator
  9. Condition unrelated to study anticipated to require indefinite anticoagulation
  10. Evidence of blood borne infection
  11. Hypersensitivity to nickel titanium alloy
  12. Allergy to radiographic contrast material which cannot be adequately premedicated
  13. Serum creatinine >2.5mg/dL
  14. The subject is enrolled in another investigational study
  15. Life expectancy is ≤ 12 months
  16. Active malignancy other than non-melanomatous skin cancer
  17. Stenosis/restenosis is located within a previously placed stent or stent graft
  18. Angiographic evidence of thrombus within or adjacent to the target lesion(s)
  19. Aneurysmal dilation proximal or distal to the target lesion(s) that could interfere with placement of the study device
  20. Abdominal aortic artery stent, if it could interfere with placement of the study device
  21. Target lesion(s) are located such that the stent graft would prevent blood flow to the internal iliac artery, if patent
  22. Lesions requiring atherectomy or ablation to facilitate stent graft delivery
  23. Any other condition deemed exclusionary in the opinion of the investigator for documented reasons relating to the health and/or welfare of the subject
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03994185
Other Study ID Numbers  ICMJE IOD-P2-19-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Merit Medical Systems, Inc.
Study Sponsor  ICMJE Merit Medical Systems, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Holden Auckland City Hospital
PRS Account Merit Medical Systems, Inc.
Verification Date April 2020

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