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

Completed · Not applicable

Conditions studied: Iliac Artery Stenosis

In brief

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.

Key facts

Study ID

NCT02793492

Run by

Terumo Medical Corporation

People needed

75

Starts

2022-08-30

Expected to finish

2026-07-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is ≥ 18 years old and of legal consent.
• Is willing to comply with all follow-up evaluations at the specified times.
• 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.
• Has a Rutherford Clinical Category Score of 2, 3 or 4.
• 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.

You may not qualify if…

• Has had previous stent or stent-graft implantation in the target lesion(s).
• 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.
• Has known hypersensitivity to contrast material that cannot be adequately pretreated.
• Has known hypersensitivity to nickel-titanium (nitinol).

Where it is running

• 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
• Cardiovascular Institute of the South — Lafayette, Louisiana, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• Novant Health — Matthews, North Carolina, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• Texas Tech University Health Sciences Center — Lubbock, Texas, United States
• The Heart Hospital Baylor Plano — Plano, Texas, United States

Full record on ClinicalTrials.gov

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