Peripheral Arterial DiseaseNCT05616143
The Isthmus Logic Post Market Clinical Follow-up Study
An observational study of Peripheral Arterial Disease, run by CID S.p.A. at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Isthmus Logic
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 1 siteItaly
- Study dates
- 4 Sep 2023to 22 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients treated less than 12 months prior to study start
Trial locations and contacts
1 site in 1 country.
About this 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.
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.
Read the 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
- Being tested
- Isthmus Logic
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isthmus LogicDevice
Patient implanted with Isthmus Logic stent for the treatment of peripheral iliac artery disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (9)
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)
Measured: 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
Measured: 6 months and 12 months
Secondary patency
Patency following successful target lesion revascularization (TLR)
Measured: 6 months and 12 months or latest patency data available
Death
Death within 30 days of the index procedure
Measured: 30 days
Clinically driven Target Lesion Revascularization
Clinically driven Target Lesion Revascularization
Measured: 6 months and 12 months
Target limb ischemia
Target limb ischemia requiring surgical intervention or surgical repair of target vessel rate
Measured: 6 months and 12 months
Rutherford category measurement
Rutherford category measurement
Measured: pretreatment, 6 months and 12 months
Evaluation of Serious Adverse Events (SAEs)
Evaluation of Serious Adverse Events (SAEs)
Measured: 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
Measured: 24/72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start4 Sep 2023
- Primary completion13 Dec 2023
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- CID S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616143
- Sponsor's protocol ID
- P22202
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05616143
- Acronym / sponsor ID
- P22202
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- CID S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients treated less than 12 months prior to study start
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isthmus LogicPatient implanted with Isthmus Logic stent for the treatment of peripheral iliac artery disease | Device | – |
Primary outcome
Rate of Major Adverse Events (MAE)
Time frame: 12 months
Composite endpoint of all causes of death, unplanned target limb major amputation and/or clinically indicated target lesion revascularization (TLR)
9 secondary outcomes
Primary patency
Time frame: 6 months and 12 months
Limb-salvage rate (LSR)
Time frame: 6 months and 12 months
Secondary patency
Time frame: 6 months and 12 months or latest patency data available
Death
Time frame: 30 days
Clinically driven Target Lesion Revascularization
Time frame: 6 months and 12 months
Target limb ischemia
Time frame: 6 months and 12 months
Rutherford category measurement
Time frame: pretreatment, 6 months and 12 months
Evaluation of Serious Adverse Events (SAEs)
Time frame: 6 months and 12 months
Acute success (device and procedural) within discharge
Time frame: 24/72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Manufactured websiteLink provided by the sponsor.
- Clinical Research OrganizationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by CID S.p.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Major Adverse Events (MAE) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.