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

Iliac Artery Stenosis Clinical Trial

— OSPREY ILIAC  

Official title:

OSPREY ILIAC: Occlusive/Stenotic Peripheral Artery REvascularization StudY for Common and/or External ILIAC Artery Using the Misago® RX Self-expanding Peripheral Stent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02793492
• Other study ID #: TIS2015-01
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Terumo Medical Corporation
• Contact: Jodie Ruffing
• Phone: 1-800-283-7866
• Email: jodie.ruffing[@]terumomedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Iliac Artery Stenosis

Intervention

Device:
• Misago® RX Self-expanding Peripheral Stent
the Misago® RX Self-expanding Stent is a bare metal, nitinol stent

Locations

Country	Name	City	State
United States	The Christ Hospital	Cincinnati	Ohio
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	Texas Tech University Health Sciences Center	Lubbock	Texas
United States	Novant Health	Matthews	North Carolina
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Cox Medical Center	Springfield	Missouri
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	ClinRe Inc. Advanced Heart and Vein Center	Thornton	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Terumo Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		9 months post-procedure
Secondary	Major Adverse Event rate at 30 days, and 12, 24, and 36 months post-procedure defined as a composite of peri-procedural related death, amputation of the target limb, and clinically driven TLR.		30 days, 12, 24, and 36 months post-procedure
Secondary	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.		9 months post-procedure
Secondary	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	The outcome is assessed up to 24 hours from time of enrollment through index procedure.
Secondary	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.	The outcome is assessed up to 24 hours from time of enrollment through index procedure
Secondary	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.	Clinical success will be evaluated from time of enrollment through index procedure. In addition, evaluation of Rutherford sustained (without increase of one or more in the score) at 9 months post-procedure from 30 days post-procedure for durability of results.	30 days post-procedure
Secondary	Ankle Brachial Index (ABI) change from baseline		through 9 months post-procedure
Secondary	Clinically driven Target Vessel Revascularization (TVR) at 30 days and 9, 12, 24, and 36 months post-procedure	TVR is defined as any re-intervention or artery bypass surgery involving the target vessel in which the subject has = 50% diameter stenosis with worsening symptoms, or = 70% stenosis without symptoms. The target vessel is defined as the vessel containing the treated lesion (e.g., common and/or external iliac artery).	30 days and 9, 12, 24, and 36 months post-procedure
Secondary	Clinically driven TLR through 30 days and 9, 12, 24, and 36 months post-procedure.	Clinically driven TLR is defined as re-intervention of the target lesion in which subject has = 50% stenosis with worsening symptoms, or = 70% stenosis without symptoms	30 days and 9, 12, 24, and 36 months post-procedure
Secondary	Walking Impairment Questionnaire		change from baseline (pre-procedure) at 30 days and 9 months post procedure
Secondary	Evaluation of all AEs		pre-discharge through 36 months post-procedure
Secondary	Evaluation of access site complications including severe bleeding, hematoma, and pseudoaneurysm, occurring prior to hospital discharge.		The event is assessed from time of enrollment through hospital discharge or up to 7 days post procedure, whichever occurs first
Secondary	Occurrence of device deficiency	n there is inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequacy in the information supplied by the manufacturer including labelling	through 36 months post-procedure
Secondary	Device Related Complications		9 months post-procedure