MicroStent
DeviceTreatment of arterial stenosis or occlusion with the MicroStent Peripheral Vascular Stent System
NCT Number: NCT04110327
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Univ.-Klinikum LKH Graz, Graz, Austria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment of arterial stenosis or occlusion with the MicroStent Peripheral Vascular Stent System
Time frame: 6 months post-procedure
Freedom from target lesion occlusion with no clinically driven target lesion revascularization (TLR)
Time frame: 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.
Time frame: 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.
Time frame: 6, 12, 24 Months
Freedom from above-ankle amputation in the target limb
Time frame: 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.
Time frame: 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.
Time frame: Procedure
Operator assessment of successful device deployment and full coverage of the lesion as intended
Time frame: 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)
Micro Medical Solution, Inc.
Industry
Acronym: HEAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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