Misago® RX Self-expanding Peripheral Stent for Common And/or External Iliac Artery (OSPREY ILIAC)

Terumo

Status: Active, not recruiting

Conditions: Iliac Artery Stenosis

Treatments: Device: Misago® RX Self-expanding Peripheral Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT02793492

TIS2015-01

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

75 participants in 1 patient group

Misago® RX Self-expanding Stent

Experimental group

Description:

Eligible participants will undergo stent implantation with the Misago® RX Self-expanding Stent

Treatment:

Device: Misago® RX Self-expanding Peripheral Stent