Critical Lower Limb Ischemia, Peripheral Arterial Disease
Conditions
Keywords
MicroStent, Below the Knee, CLI, Below the Ankle, CLTI
Brief summary
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
Detailed description
Subjects with peripheral arterial disease (PAD) whom the investigator has treated or intends to treat with the MicroStent™ System per the current instructions for use (IFU), and who have given written informed consent, will be enrolled in this study. Up to 300 subjects will be enrolled: The objective of this post market registry is to evaluate procedural and long-term clinical outcomes for subjects undergoing intervention with the MicroStent® System for treatment of lower extremity peripheral arterial disease (PAD), presenting with below-the-knee lesions.
Interventions
DEVICEMicroStent
Treatment of arterial stenosis or occlusion with the MicroStent Peripheral Vascular Stent System
Sponsors
Micro Medical Solution, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Any subject with below the knee, at the ankle level or below the ankle peripheral arterial lesions previously treated or intended to be treated with the MicroStent® System per the current indications for use 2. For across the ankle joint intervention, distal runoff to digital branches or arcuate arteries must be present on angiography prior to MicroStent deployment 3. Subject's age is ≥ 18 years. 4. Subject must be willing to sign a patient informed consent form.
Exclusion criteria
1. Subject is pregnant or planning to become pregnant during the study duration 2. Subject has a life expectancy of less than one (1) year 3. Subject has a known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications 4. Subject is enrolled in another study that has not reached its primary endpoint at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency | 6 months post-procedure | Freedom from target lesion occlusion with no clinically driven target lesion revascularization (TLR) |
| Freedom from Perioperative Death and Major Adverse Limb Events (MALE) | 30 days post-procedure | Freedom from all-cause death or major adverse limb events. Major adverse limb events include above-ankle amputation, new bypass graft or graft revision, and thrombectomy or thrombolysis involving the target lesion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Major Adverse Limb Events | 6, 12, 24 Months | Major adverse limb events include above-ankle amputation, new bypass graft or graft revision, and thrombectomy or thrombolysis involving the target lesion. |
| Freedom from Major Amputation | 6, 12, 24 Months | Freedom from above-ankle amputation in the target limb |
| Freedom from Clinically Driven Target Lesion Revascularization (TLR) | 6, 12, 24 Months | Freedom from any revascularization procedure with involvement of the target lesion that is due to complaints of leg pain or worsening leg pain, a progressing, non-healing ulcer, or new ulcer formation with or without the presence of an abnormal non-invasive test. |
| Wound Healing | 30 days, 6, 12, 24 Months | Wounds will be identified at the baseline visit and classified as fully healed or not healed at each follow up visit. |
| Device Success | Procedure | Operator assessment of successful device deployment and full coverage of the lesion as intended |
| Technical Success | Procedure | Attainment of less than or equal to 30% residual stenosis by visual estimate in the treated lesion using only the study device according to the IFU (i.e. including post dilation at the discretion of the investigator) |
Countries
Austria, Belgium, Germany, Italy, Netherlands
Outcome results
None listed