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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04110327
Other study ID # MMS-201
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 31, 2019
Est. completion date January 31, 2024

Study information

Verified date April 2022
Source Micro Medical Solution, Inc.
Contact Esmeralda Sanjust di Teulada
Phone (415) 370-6757
Email esmeraldas@micromedicalsolutions.net
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.


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 250 subjects in three cohorts will be enrolled: Up to 100 subjects or 1-year recruitment, whichever comes first in Cohort #1: Claudication; Rutherford ≤3 Up to 100 subjects or 1-year recruitment, whichever comes first in Cohort #2: Critical Limb Ischemia; Rutherford 4-5 Up to 50 subjects or 1-year recruitment, whichever comes first in Cohort #3: Critical Limb Ischemia w/major tissue loss; Rutherford 6 Sites may follow routine follow up intervals per their standard of care, with data regarding clinical assessments regarding limb status being collected. Data from these visits that do not fall in the expected visit windows will be captured in the study database as unscheduled visits.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date January 31, 2024
Est. primary completion date July 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Any subject with peripheral arterial lesions previously treated or intended to be treated with the MicroStent™ System per the current indications for use. 2. Age =18 years old 3. Patient must be willing to sign a patient informed consent form Exclusion Criteria: 1. Subject is pregnant or is planning to become pregnant during the course of the study. 2. Life expectancy of less than 1 year. 3. Known allergy to concomitant medications, 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.

Study Design


Intervention

Device:
MicroStent
Treatment of arterial stenosis or occlusion with the MicroStent Perihperal Vascular Stent System

Locations

Country Name City State
Austria Univ.-Klinikum LKH Graz Graz
Belgium OLV Hospital Aalst
Belgium A.Z. Sint-Blasius Dendermonde
Belgium ZOL Genk Genk
Germany Klinikum Hochsauerland - Karolinen Hospital Arnsberg
Germany University of Leipzig Leipzig Saxony
Italy Policlinico Abano Terme Abano Terme
Italy Maria Cecilia Hospital Cotignola
Netherlands St. Antonius Ziekenhuis Nieuwegein

Sponsors (1)

Lead Sponsor Collaborator
Micro Medical Solution, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Italy,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Patency Freedom from target lesion occlusion with no clinically driven target lesion revascularization (TLR) 6 months post-procedure
Primary 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
Secondary 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
Secondary Freedom from Major Amputation Freedom from above-ankle amputation in the target limb 6, 12, 24 Months
Secondary 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
Secondary 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
Secondary Device Success Operator assessment of successful device deployment and full coverage of the lesion as intended Procedure
Secondary 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
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