Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
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.
Study Type
OBSERVATIONAL
Enrollment
300
Treatment of arterial stenosis or occlusion with the MicroStent Peripheral Vascular Stent System
Univ.-Klinikum LKH Graz
Graz, Austria
OLV Hospital
Aalst, Belgium
A.Z. Sint-Blasius
Dendermonde, Belgium
ZOL Genk
Genk, Belgium
Primary Patency
Freedom from target lesion occlusion with no clinically driven target lesion revascularization (TLR)
Time frame: 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.
Time frame: 30 days post-procedure
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.
Time frame: 6, 12, 24 Months
Freedom from Major Amputation
Freedom from above-ankle amputation in the target limb
Time frame: 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.
Time frame: 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.
Time frame: 30 days, 6, 12, 24 Months
Device Success
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Operator assessment of successful device deployment and full coverage of the lesion as intended
Time frame: 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)
Time frame: Procedure