An observational study in Peripheral Arterial Disease, sponsored by CID S.p.A.. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by CID S.p.A. · Observational
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.
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.
1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.
This study's enrollment of 37 is below the median of 190 across 427 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →CID S.p.A. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient implanted with Isthmus Logic stent for the treatment of peripheral iliac artery disease
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)
Time frame: 12 months
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)
Time frame: 6 months and 12 months
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
Time frame: 6 months and 12 months
Secondary patency
Patency following successful target lesion revascularization (TLR)
Time frame: 6 months and 12 months or latest patency data available
Death
Death within 30 days of the index procedure
Time frame: 30 days
Clinically driven Target Lesion Revascularization
Clinically driven Target Lesion Revascularization
Time frame: 6 months and 12 months
Target limb ischemia
Target limb ischemia requiring surgical intervention or surgical repair of target vessel rate
Time frame: 6 months and 12 months
Rutherford category measurement
Rutherford category measurement
Time frame: pretreatment, 6 months and 12 months
Evaluation of Serious Adverse Events (SAEs)
Evaluation of Serious Adverse Events (SAEs)
Time frame: 6 months and 12 months
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
Time frame: 24/72 hours
Plan to share: No
Ran from Sep 2023 to primary completion in Dec 2023, 3 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: start Feb 2023 → Sep 2023, primary completion Jun 2023 → Dec 2023 and completion Jul 2023 → May 2024.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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CID S.p.A.