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

NCT03994185 | Withdrawn DMC FDA Device

• 1 other identifier: IOD-P2-19-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stenosis of Artery; Peripheral Arterial Disease; Iliac Artery Disease; Iliac Artery Occlusion

Keywords

PAOD; Peripheral Arterial Occlusive Disease; Iliac Artery Disease; Stent Graft

Outcome Measures

Primary Outcomes (3)

• Safety endpoint of subjects free from specified adverse events

  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.

  4 weeks after placement of WRAPSODY stent graft

• Effectiveness endpoint of subjects with improvement of Rutherford Category

  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.

  4 weeks after placement of WRAPSODY stent graft

• Effectiveness endpoint of subjects with patency

  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.

  4 weeks after placement of WRAPSODY stent graft

Study Arms (1)

Group Treated with stent graft

EXPERIMENTAL

This is a single arm study. All subjects will be treated with the WRAPSODY stent graft.

Device: Placement of WRAPSODY stent graft

Interventions

Placement of WRAPSODY stent graft DEVICE

Placement of WRAPSODY stent graft into the iliac arteries and/or aortic bifurcation.

Group Treated with stent graft

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed informed consent
• Subject is ≥ 21 years of age
• Subject is able and willing to comply with study requirements
• Male, infertile female, or female practicing contraception and a negative pregnancy test within 7 days prior to the study procedure
• Symptomatic claudication or rest pain without tissue loss, Rutherford category 2-4
• 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)
• Total lesion(s) length is ≤ 110mm
• Target lesion(s) is at least 3 cm from an existing stent or stent graft
• At least 1 stenosis in the target vessel has ≥ 50% stenosis
• Target vessel diameter is between 4.6 and 14.4mm at angiographic screening for device placement
• Adequate ipsilateral blood flow, including at least 1 patent (\<50% stenotic) superficial femoral or profundal femoral artery
• 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

You may not qualify if:

• Subject has undergone an intervention (surgical or percutaneous) in the target limb(s) \<30 days from the date of the index study procedure
• Subject has a surgical or percutaneous procedure in the target limb(s) planned within 30 days following the index study procedure
• Previous or planned bypass surgery in the target limb(s)
• Coronary intervention within 30 days prior to enrollment or planned within 12 months after index study procedure
• Subject has had a stroke within 90 days prior to the index study procedure
• Subject has had a transient ischemic attack within 30 days prior to the index study procedure
• Uncorrectable coagulation disorder
• Subject cannot receive heparin, dual antiplatelet treatment, or anticoagulant(s) appropriate in the opinion of the investigator
• Condition unrelated to study anticipated to require indefinite anticoagulation
• Evidence of blood borne infection
• Hypersensitivity to nickel titanium alloy
• Allergy to radiographic contrast material which cannot be adequately premedicated
• Serum creatinine \>2.5mg/dL
• The subject is enrolled in another investigational study
• Life expectancy is ≤ 12 months

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease 1

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Andrew Holden

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Approximately 30 subjects will be enrolled and treated with the study device

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: September 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: December 31, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share