An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

— HEAL  

Official title:

An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04110327
• Other study ID #: MMS-201
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Critical Lower Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Diseases

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