Observational study of the MicroStent™ System for treating peripheral arterial disease

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

This study is testing how well the MicroStent™ System works for treating patients with peripheral arterial disease who have blockages below the knee.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Micro Medical Solution, Inc. (Industry-sponsored)
• Locations: 10 sites (Graz and 9 other locations)
• Trial ID: NCT04110327 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the procedural and long-term clinical outcomes of the MicroStent™ Peripheral Vascular Stent System in patients with peripheral arterial disease (PAD) who have below-the-knee lesions. The study will enroll up to 300 subjects who have been treated or are intended to be treated with the MicroStent™ System, following the current instructions for use. It combines both prospective and retrospective cohort analyses to gather comprehensive data on the effectiveness of this intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with below-the-knee or below-ankle peripheral arterial lesions who are being treated with the MicroStent™ System.

Not a fit: Patients who are pregnant, have a life expectancy of less than one year, or have known allergies to necessary medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of the MicroStent™ System for patients suffering from peripheral arterial disease.

How similar studies have performed: While this study is observational and builds on existing knowledge, similar approaches have shown promise in evaluating stent systems for peripheral arterial disease.

Eligibility criteria

Inclusion Criteria:

1. Any subject with below the knee, at the ankle level or below the ankle peripheral arterial lesions previously treated or intended to be treated with the MicroStent® System per the current indications for use
2. For across the ankle joint intervention, distal runoff to digital branches or arcuate arteries must be present on angiography prior to MicroStent deployment
3. Subject's age is ≥ 18 years.
4. Subject must be willing to sign a patient informed consent form.

Exclusion Criteria:

1. Subject is pregnant or planning to become pregnant during the study duration
2. Subject has a life expectancy of less than one (1) year
3. Subject has a known allergy to concomitant medication, 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.

Where this trial is running

Graz and 9 other locations

• Univ.-Klinikum LKH Graz — Graz, Austria (Recruiting)
• OLV Hospital — Aalst, Belgium (Recruiting)
• A.Z. Sint-Blasius — Dendermonde, Belgium (Recruiting)
• ZOL Genk — Genk, Belgium (Recruiting)
• Klinikum Hochsauerland - Karolinen Hospital — Arnsberg, Germany (Recruiting)
• University Heart Center Freiburg - Bad Krozingen — Bad Krozingen, Germany (Recruiting)
• University of Leipzig — Leipzig, Germany (Recruiting)
• Policlinico Abano Terme — Abano Terme, Italy (Recruiting)
• Maria Cecilia Hospital — Cotignola, Italy (Recruiting)
• St. Antonius Ziekenhuis — Nieuwegein, Netherlands (Recruiting)

Study contacts

• Study coordinator: Rita Jacob

Conditions Peripheral Arterial Disease; Critical Lower Limb Ischemia; MicroStent; Below the Knee; CLI; Below the Ankle; CLTI