Clinical trial NCT04110327: An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects with Peripheral Arterial Disease
Official title: An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects with Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Critical Lower Limb Ischemia
Keywords: MicroStent
Below the Knee
CLI
Below the Ankle
CLTI
Lead sponsor: Micro Medical Solution, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include any subject with symptomatic peripheral arterial disease (PAD) that require intervention with the MicroStent™ System.

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

Detailed 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 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.

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.

Primary outcomes:
measure: Primary Patency
timeFrame: 6 months post-procedure
measure: Freedom from Perioperative Death and Major Adverse Limb Events (MALE)
timeFrame: 30 days post-procedure
Secondary outcomes:
measure: Freedom from Major Adverse Limb Events
timeFrame: 6, 12, 24 Months
measure: Freedom from Major Amputation
timeFrame: 6, 12, 24 Months
measure: Freedom from Clinically Driven Target Lesion Revascularization (TLR)
timeFrame: 6, 12, 24 Months
measure: Wound Healing
timeFrame: 30 days, 6, 12, 24 Months
measure: Device Success
timeFrame: Procedure
measure: Technical Success
timeFrame: Procedure
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Univ.-Klinikum LKH Graz
city: Aalst
country: Belgium
facility: OLV Hospital
city: Dendermonde
country: Belgium
facility: A.Z. Sint-Blasius
city: Genk
country: Belgium
facility: ZOL Genk
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland - Karolinen Hospital
city: Bad Krozingen
country: Germany
facility: University Heart Center Freiburg - Bad Krozingen
city: Leipzig
country: Germany
facility: University of Leipzig
city: Abano Terme
country: Italy
facility: Policlinico Abano Terme
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
Study officials:
References: