NCT05616143

The Isthmus Logic Post Market Clinical Follow-up Study

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: CID S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Isthmus Logic	Patient implanted with Isthmus Logic stent for the treatment of peripheral iliac artery disease

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-06-01
• Completion: 2023-07-01
• First posted: 2022-11-15
• Last updated: 2022-11-15

Locations

1 site across 1 country: Italy