Clinical trial NCT02793492: Misago® RX Self-expanding Peripheral Stent for Common And/or External Iliac Artery
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Iliac Artery Stenosis
Lead sponsor: Terumo Medical Corporation
Sponsor class: INDUSTRY
First posted: 2016-06-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: 9 months post-procedure
Secondary outcomes:
measure: 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.
timeFrame: 30 days, 12- and 24- months post-procedure
measure: 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.
timeFrame: 9 months post-procedure
measure: 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
timeFrame: The outcome is assessed up to 24 hours from time of enrollment through index procedure.
measure: Procedural Success: Attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications.
timeFrame: The outcome is assessed up to 24 hours from time of enrollment through index procedure
measure: 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.
timeFrame: 30 days post-procedure
measure: Ankle Brachial Index (ABI) change from baseline
timeFrame: through 9 months post-procedure
measure: Clinically driven Target Vessel Revascularization (TVR) at 30 days and 9, 12- and 24- months post-procedure
timeFrame: 30 days and 9, 12 and 24 months post-procedure
measure: Clinically driven TLR through 30 days and 9-, 12- and 24-months post-procedure.
timeFrame: 30 days and 9-, 12- and 24-months post-procedure
measure: Walking Impairment Questionnaire
timeFrame: change from baseline (pre-procedure) at 30 days and 9 months post procedure
measure: Evaluation of all AEs
timeFrame: pre-discharge through 24 months post-procedure
measure: Evaluation of access site complications including severe bleeding, hematoma, and pseudoaneurysm, occurring prior to hospital discharge.
timeFrame: The event is assessed from time of enrollment through hospital discharge or up to 7 days post procedure, whichever occurs first
measure: Occurrence of device deficiency
timeFrame: through 24 months post-procedure
measure: Device Related Complications
timeFrame: 9 months post-procedure
Other outcomes:
Locations:
city: Thornton
country: United States
facility: ClinRe Inc. Advanced Heart and Vein Center
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Lafayette
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Matthews
country: United States
facility: Novant Health
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
Study officials:
affiliation: Holy Name Medical Center
name: John Rundback, MD
role: PRINCIPAL_INVESTIGATOR
References: