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Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStentâ„¢ System.
Subjects with peripheral arterial disease (PAD) whom the investigator has treated or intends to treat with the MicroStentâ„¢ 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MicroStent | Device | Treatment of arterial stenosis or occlusion with the MicroStent Peripheral Vascular Stent System |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency | Freedom from target lesion occlusion with no clinically driven target lesion revascularization (TLR) | 6 months post-procedure |
| Freedom from Perioperative Death and Major Adverse Limb Events (MALE) | 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. | 30 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from 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. | 6, 12, 24 Months |
| Freedom from Major Amputation |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include any subject with symptomatic peripheral arterial disease (PAD) that require intervention with the MicroStentâ„¢ System.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ.-Klinikum LKH Graz | Graz | Austria | ||||
| OLV Hospital |
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Freedom from above-ankle amputation in the target limb
| 6, 12, 24 Months |
| Freedom from Clinically Driven Target Lesion Revascularization (TLR) | 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. | 6, 12, 24 Months |
| Wound Healing | Wounds will be identified at the baseline visit and classified as fully healed or not healed at each follow up visit. | 30 days, 6, 12, 24 Months |
| Device Success | Operator assessment of successful device deployment and full coverage of the lesion as intended | Procedure |
| Technical Success | 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) | Procedure |
| Aalst |
| Belgium |
| A.Z. Sint-Blasius | Dendermonde | Belgium |
| ZOL Genk | Genk | Belgium |
| Klinikum Hochsauerland - Karolinen Hospital | Arnsberg | Germany |
| University Heart Center Freiburg - Bad Krozingen | Bad Krozingen | Germany |
| University of Leipzig | Leipzig | Germany |
| Policlinico Abano Terme | Abano Terme | Italy |
| Maria Cecilia Hospital | Cotignola | Italy |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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