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The Merit WRAPSODY™ Endovascular Stent Graft

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: NCT03644017
Recruitment Status : Active, not recruiting
First Posted : August 23, 2018
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Merit Medical Systems, Inc.

Brief Summary:
This is a phase 1 study, designed to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of venous outflow circuit obstructions in the veins of the arm or thoracic central veins of subjects who receive chronic dialysis treatment for end stage renal disease.

Condition or disease Intervention/treatment Phase
Venous Stenosis Venous Occlusion Device: WRAPSODY Stent Graft Placement Not Applicable

Detailed Description:

The study will consist of a screening period in which subject eligibility will be determined. Approximately 50 subjects meeting the study entry criteria will be enrolled. Placement of the WRAPSODY stent graft will follow the procedure. Post study procedure subjects will have planned follow-up visits at 30 days, 3, 6 and 12months, and additional visits as referred by the subject's dialysis facility.

The primary study safety endpoint will be the proportion of subjects without any localized or systemic safety events through 30 days that affect the access or venous outflow circuit and resulted in surgery, hospitalization, or death. Subjects will continue to be followed up to 12 months for supplementary information.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm treated with investigational device WRAPSODY Stent Graft
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Venous Outflow Circuit Obstruction In Hemodialysis Patients
Actual Study Start Date : January 29, 2019
Actual Primary Completion Date : February 25, 2020
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: WRAPSODY Stent Graft
All subjects will receive treatment via WRAPSODY Stent Graft Placement.
Device: WRAPSODY Stent Graft Placement
The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Other Names:
  • Stent Graft
  • Covered Stent




Primary Outcome Measures :
  1. Proportion of subjects without any localized or systemic safety events through 30 days [ Time Frame: 30 days ]
    Proportion of subjects without any localized or systemic safety events through 30 days that affect the access or venous outflow circuit and resulted in surgery, hospitalization, or death


Secondary Outcome Measures :
  1. Target Lesion Primary Patency [ Time Frame: 3 months ]
    Proportion of subjects with Target Lesion Primary Patency at 3 months

  2. Primary Patency of the venous outflow circuit at 3 months [ Time Frame: 3 months ]
    Proportion of subjects with Primary Patency of the venous outflow circuit at 3 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has signed informed consent
  2. Subject is ≥ 21 years of age
  3. Subject is undergoing chronic hemodialysis or other forms of renal replacement therapy including transplantation and has one of the following being used: a. AV graft placed in the arm ≥30 days prior OR b. Mature fistula in the arm with at least one successful dialysis session completed
  4. Angiographic evidence of stenosis
  5. The target lesion has ≥ 50% stenosis
  6. Subject has clinical or hemodynamic evidence of a venous outflow stenosis or obstruction
  7. Full expansion of an appropriately sized 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) of the AVF/AVG <30 days from the date of the initial study procedure
  2. Subject has had a previous stent or stent graft placed in the venous outflow circuit ≤30 days from the date of the initial study procedure
  3. Active hemodialysis access is not in the arm
  4. A pseudoaneurysm is present within the target lesion
  5. Target lesion is in SVC, IJV, under the clavicle, across the elbow, in the needling segment of AVF or AVG anastomosis, located within a stent
  6. Lesions, other than the target lesion, in the venous outflow circuit with >30% stenosis
  7. Known or suspected infection of the hemodialysis access site and/or septicemia
  8. Permanent pacemaker or automated implantable cardioverter defibrillator (AICD) on the side with the target lesion
  9. Current central venous catheter for dialysis access
  10. Uncorrectable coagulation disorders
  11. Hypersensitivity to nickel titanium alloy
  12. The subject is enrolled in another investigational study
  13. The subject is unable or unwilling to comply with the protocol requirements
  14. Life expectancy is ≤ 12 months
  15. Subject cannot receive heparin or equivalent anticoagulant
  16. Allergy to radiographic contrast material which cannot be adequately premedicated
  17. Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant
  18. Subject's access is anticipated to be abandoned within 3 months
  19. Subject has a thoracic central vein obstruction that would lead to stent graft placement across the internal jugular vein
  20. Subject's hemodialysis access is thrombosed
  21. Active malignancy other than non-melanomatous skin cancer
  22. Any other condition deemed exclusionary in the opinion of the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644017


Locations
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Greece
G. Gennimatas General Hospital of Athens
Athens, Greece, 115 27
United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
Merit Medical Systems, Inc.
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Responsible Party: Merit Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT03644017    
Other Study ID Numbers: CVO-P1-18-01
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Merit Medical Systems, Inc.:
Dialysis
Venous Stenosis
Venous Occlusion
Stent Graft
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical