Iliac Artery Stenosis
Conditions
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.
Interventions
DEVICEMisago® RX Self-expanding Peripheral Stent
the Misago® RX Self-expanding Stent is a bare metal, nitinol stent
Sponsors
Terumo Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | 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 | The outcome is assessed up to 24 hours from time of enrollment through index procedure. | Technical success will be evaluated from time of enrollment through index procedure |
| Procedural Success: Attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications. | The outcome is assessed up to 24 hours from time of enrollment through index procedure | 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. |
| 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. | 30 days post-procedure | 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. |
| Ankle Brachial Index (ABI) change from baseline | through 9 months post-procedure | — |
| Clinically driven Target Vessel Revascularization (TVR) at 30 days and 9, 12- and 24- months post-procedure | 30 days and 9, 12 and 24 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). |
| Clinically driven TLR through 30 days and 9-, 12- and 24-months post-procedure. | 30 days and 9-, 12- and 24-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 |
| Walking Impairment Questionnaire | change from baseline (pre-procedure) at 30 days and 9 months post procedure | — |
| Evaluation of all AEs | pre-discharge through 24 months post-procedure | — |
| 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 | — |
| Occurrence of device deficiency | through 24 months post-procedure | A device deficiency has occurred when 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 |
| Device Related Complications | 9 months post-procedure | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn Rundback, MD
Holy Name Medical Center
STUDY_DIRECTORCharis Sugden
Terumo Medical Corporation
Outcome results
None listed