Clinical Trials in Italy / NCT04110327
Active, not recruiting
Observational
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
NCT04110327 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Peripheral Arterial DiseaseCritical Lower Limb Ischemia
Investigational drug(s) / intervention(s)
MicroStent
MicroStent: Treatment of arterial stenosis or occlusion with the MicroStent Peripheral Vascular Stent System
Study summary
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
Eligibility
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.
Primary outcome measure(s)
- Primary Patency — 6 months post-procedure
Freedom from target lesion occlusion with no clinically driven target lesion revascularization (TLR) - Freedom from Perioperative Death and Major Adverse Limb Events (MALE) — 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.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Univ.-Klinikum LKH Graz | Graz | Austria | |
| OLV Hospital | Aalst | Belgium | |
| A.Z. Sint-Blasius | Dendermonde | Belgium | |
| ZOL Genk | Genk | Belgium | |
| 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 |
Other trials for the same condition
SELUTION4BTK Trial
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04110327 on ClinicalTrials.gov ↗ ← All trials in Italy