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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misago® RX Self-expanding Stent | Experimental | Eligible participants will undergo stent implantation with the Misago® RX Self-expanding Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misago® RX Self-expanding Peripheral Stent | Device | the Misago® RX Self-expanding Stent is a bare metal, nitinol stent |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Rundback, MD | Holy Name Medical Center | Principal Investigator |
| Charis Sugden | Terumo Medical Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClinRe Inc. Advanced Heart and Vein Center | Thornton | Colorado | 80023 | United States | ||
| University of Florida Health |
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| 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 | 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. |
| 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 |
| 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 |
| 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 | 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 and 24 months post-procedure |
| Clinically driven TLR through 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 | 30 days and 9-, 12- and 24-months post-procedure |
| 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 | 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 | through 24 months post-procedure |
| Device Related Complications | 9 months post-procedure |
| Gainesville |
| Florida |
| 32610 |
| United States |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32256 | United States |
| Cardiovascular Institute of the South | Lafayette | Louisiana | 70506 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| Novant Health | Matthews | North Carolina | 28105 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |