N/A N=46 Treatment

The Merit WRAPSODY™ Endovascular Stent Graft

Venous Stenosis · Venous Occlusion

Bottom Line

View on ClinicalTrials.gov: NCT03644017 ↗

Enrolled (actual)

Serious AEs

21.7%

Results posted

Jul 2021

Primary outcome: Primary: Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days — 45 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: WRAPSODY Stent Graft Placement (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Merit Medical Systems, Inc.
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days	45	—
PRIMARY Number of Participants With Target Lesion Primary Patency at 30 Days	45	—
SECONDARY Number of Participants With Target Lesion Primary Patency at 3 Months	44	—
SECONDARY Number of Participants With Target Lesion Primary Patency at 6 Months	42	—
SECONDARY Number of Participants With Target Lesion Primary Patency at 12 Months	33	—
SECONDARY Number of Participants With Assisted Target Lesion Primary Patency at 30 Days	45	—
SECONDARY Number of Participants With Assisted Target Lesion Primary Patency at 3 Months	44	—
SECONDARY Number of Participants With Assisted Target Lesion Primary Patency at 6 Months	43	—
SECONDARY Number of Participants With Assisted Target Lesion Primary Patency at 12 Months	39	—
SECONDARY Number of Participants With Access Circuit Primary Patency at 30 Days	43	—
SECONDARY Number of Participants With Access Circuit Primary Patency at 3 Months	40	—
SECONDARY Number of Participants With Access Circuit Primary Patency at 6 Months	38	—
SECONDARY Number of Participants With Access Circuit Primary Patency at 12 Months	29	—
SECONDARY Number of Participants With Assisted Access Circuit Primary Patency at 30 Days	45	—
SECONDARY Number of Participants With Assisted Access Circuit Primary Patency at 3 Months	44	—
SECONDARY Number of Participants With Assisted Access Circuit Primary Patency at 6 Months	43	—
SECONDARY Number of Participants With Assisted Access Circuit Primary Patency at 12 Months	39	—
SECONDARY Number of Participants With Clinical Success	45	—
SECONDARY Number of Participants With Anatomic Success	46	—
SECONDARY Number of Participants With Procedural Success	45	—

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.

Eligibility Criteria

Inclusion Criteria

Subject has signed informed consent
Subject is ≥ 21 years of age
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
Angiographic evidence of stenosis
The target lesion has ≥ 50% stenosis
Subject has clinical or hemodynamic evidence of a venous outflow stenosis or obstruction
Full expansion of an appropriately sized standard angioplasty balloon has been achieved during primary angioplasty at the target lesion prior to enrollment

Exclusion Criteria

Subject has undergone an intervention (surgical or percutaneous) of the AVF/AVG 30% stenosis
Known or suspected infection of the hemodialysis access site and/or septicemia
Permanent pacemaker or automated implantable cardioverter defibrillator (AICD) on the side with the target lesion
Current central venous catheter for dialysis access
Uncorrectable coagulation disorders
Hypersensitivity to nickel titanium alloy
The subject is enrolled in another investigational study
The subject is unable or unwilling to comply with the protocol requirements
Life expectancy is ≤ 12 months
Subject cannot receive heparin or equivalent anticoagulant
Allergy to radiographic contrast material which cannot be adequately premedicated
Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant
Subject's access is anticipated to be abandoned within 3 months
Subject has a thoracic central vein obstruction that would lead to stent graft placement across the internal jugular vein
Subject's hemodialysis access is thrombosed
Active malignancy other than non-melanomatous skin cancer
Any other condition deemed exclusionary in the opinion of the investigator

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03644017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.