Clinical trial NCT05616143: The Isthmus Logic Post Market Clinical Follow-up Study
Official title: A Cobalt Chromium Stent With a Bio Inducer Surface for the Treatment of Peripheral Iliac Artery Disease: Evaluation of Safety and Performance in Everyday Clinical Practice. The Isthmus Logic Post Market Clinical Follow-up Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Lead sponsor: CID S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Meditrial Europe Ltd.
First posted: 2022-11-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by peripheral iliac artery disease implanted with at least one study device at least 12 months prior to the start date of the retrospective data collection.

Brief summary: Isthmus Logic Carbostent™ is a CE-marked cobalt chromium stent with a bio inducer surface for the treatment of peripheral iliac artery disease.

The aim of this post-market retrospective study protocl P22202 is to collect clinical data of patients treated with Isthmus Logic for the treatment of peripheral iliac artery disease in routine clinical practice.

In order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with these devices at least 12 months prior to the study start.

Detailed description: The objective of this post-market study is to systematically collect retrospective clinical data on the implantable medical device Isthmus Logic in the daily clinical practice in an unselected population treated within the intended use. Data will be collected via medical chart review in anonymous form to assess the safety and efficacy of Isthmus Logic. The Isthmus Logic Carbostent™ stent is made of cobalt chromium alloy and is coated with iCarbofilm™, a thin carbon film with a high-density turbostratic structure substantially identical with that of the pyrolitic carbon used for mechanical cardiac valve discs. Coating the substrate provides it with the bio- and haemocompatible characteristics of pyrolitic carbon, without affecting the physical and structural properties of the substrate itself.

Two radio-opaque platinum markers at either end of the stent allow for accurate positioning over the lesion to be treated.

Eligibility criteria: Inclusion Criteria:

* Patient has been implanted with at least one Isthmus Logic stent according to the indications described in the Instructions for Use (IFU).
* Study device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collection.

Exclusion Criteria:

* Patients treated less than 12 months prior to study start

Primary outcomes:
measure: Rate of Major Adverse Events (MAE)
timeFrame: 12 months
Secondary outcomes:
measure: Primary patency
timeFrame: 6 months and 12 months
measure: Limb-salvage rate (LSR)
timeFrame: 6 months and 12 months
measure: Secondary patency
timeFrame: 6 months and 12 months or latest patency data available
measure: Death
timeFrame: 30 days
measure: Clinically driven Target Lesion Revascularization
timeFrame: 6 months and 12 months
measure: Target limb ischemia
timeFrame: 6 months and 12 months
measure: Rutherford category measurement
timeFrame: pretreatment, 6 months and 12 months
measure: Evaluation of Serious Adverse Events (SAEs)
timeFrame: 6 months and 12 months
measure: Acute success (device and procedural) within discharge
timeFrame: 24/72 hours
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale San Raffaele
Study officials:
References: