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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05616143
Other study ID # P22202
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 2023
Est. completion date July 2023

Study information

Verified date November 2022
Source CID S.p.A.
Contact Franco Vallana, MD
Phone +39 0161 18261
Email franco.vallana@alvimedica.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date July 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Isthmus Logic
Patient implanted with Isthmus Logic stent for the treatment of peripheral iliac artery disease

Locations

Country Name City State
Italy Ospedale San Raffaele Milano

Sponsors (2)

Lead Sponsor Collaborator
CID S.p.A. Meditrial Europe Ltd.

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Major Adverse Events (MAE) Composite endpoint of all causes of death, unplanned target limb major amputation and/or clinically indicated target lesion revascularization (TLR) 12 months
Secondary Primary patency Primary patency is defined as absence of clinically-driven target lesion revascularization or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) >2.4 (Duplex Ultrasound evaluation) 6 months and 12 months
Secondary Limb-salvage rate (LSR) Limb-salvage rate (LSR) is defined as rate of patients free from major amputation. Major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot 6 months and 12 months
Secondary Secondary patency Patency following successful target lesion revascularization (TLR) 6 months and 12 months or latest patency data available
Secondary Death Death within 30 days of the index procedure 30 days
Secondary Clinically driven Target Lesion Revascularization Clinically driven Target Lesion Revascularization 6 months and 12 months
Secondary Target limb ischemia Target limb ischemia requiring surgical intervention or surgical repair of target vessel rate 6 months and 12 months
Secondary Rutherford category measurement Rutherford category measurement pretreatment, 6 months and 12 months
Secondary Evaluation of Serious Adverse Events (SAEs) Evaluation of Serious Adverse Events (SAEs) 6 months and 12 months
Secondary Acute success (device and procedural) within discharge Clinical device success defined as successful delivery and deployment of the stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple stents) and final residual stenosis of the target lesion minor or equal to 30%, assessed by visual estimation and clinical device success without the occurrence of MAE during the hospital stay 24/72 hours
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