Misago® RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery

N/AActive Not RecruitingNCT02793492

Terumo Medical Corporation75 enrolled

Overview

This is a multi-center, single arm, non-randomized, prospective clinical study using the Misago® RX Self-expanding Peripheral Stent for treatment of de novo, restenotic, and/or occlusive lesion(s) of the common and/or external iliac artery.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Iliac Artery Stenosis

Interventions

Misago® RX Self-expanding Peripheral StentDEVICE

the Misago® RX Self-expanding Stent is a bare metal, nitinol stent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Is ≥ 18 years old and of legal consent. 2. Is willing to comply with all follow-up evaluations at the specified times. 3. Subject or subject's legal representative has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. 4. Has a Rutherford Clinical Category Score of 2, 3 or 4. 5. Radiographic evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s) in the common iliac artery and/or external iliac artery. Exclusion Criteria: 1. Has had previous stent or stent-graft implantation in the target lesion(s). 2. Has a contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug used during the study according to the protocol. 3. Has known hypersensitivity to contrast material that cannot be adequately pretreated. 4. Has known hypersensitivity to nickel-titanium (nitinol).

Locations (9)

ClinRe Inc. Advanced Heart and Vein Center

Thornton, Colorado, United States

University of Florida Health

Gainesville, Florida, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Freedom from the composite Major Adverse Event rate, defined as periprocedural related death, amputation of the target limb, and clinically driven TLR assessed at 9 months post-procedure.

Time frame: 9 months post-procedure

Secondary Outcomes

Major Adverse Event rate at 30 days, and 12- and 24- months post-procedure defined as a composite of peri-procedural related death, amputation of the target limb, and clinically driven TLR.

Time frame: 30 days, 12- and 24- months post-procedure

Primary stent patency at 9 months defined by a binary duplex ultrasound peak systolic velocity ratio ≤ 2.4 at the stented target lesion and absence of TLR.

Time frame: 9 months post-procedure

Technical Success defined by the following conditions: 1) Successful delivery of the stent at the lesion site 2) Stent(s) successfully deployed in lesion with adequate lesion coverage

Technical success will be evaluated from time of enrollment through index procedure

Time frame: The outcome is assessed up to 24 hours from time of enrollment through index procedure.

Procedural Success: Attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications.

Procedural success will be evaluated from time of enrollment through index procedure. Peri-procedural complications defined as: death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel.

Time frame: The outcome is assessed up to 24 hours from time of enrollment through index procedure

Clinical Success: Relief or improvement (without increase of one or more in the score) from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline.

Data from ClinicalTrials.gov

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