Peripheral Arterial DiseaseNCT05616156
The Cre8™ BTK Post Market Clinical Follow-up Study
An observational study of Peripheral Arterial Disease, run by CID S.p.A. at 2 sites in Italy.
Trial summary
Cre8™ BTK is a CE marked drug eluting stent, integrally coated with i-Carbofilm, loaded with formulated Sirolimus for the treatment of infrapopliteal peripheral artery disease. The aim of this post-market retrospective study protocol P32102 is to collect clinical data of patient treated with Cre8™ BTK stent in routine… 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?
- Cre8™ BTK
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- 12 Apr 2023to 31 Jan 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 with infrapopliteal ischemic obstruction, implanted with at least one Cre8™ BTK drug eluting stent 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 Cre8™ BTK device 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
2 sites in 1 country.
Italy2 sites
Pliclinico Abano terme
Abano Terme, Padova
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria
About this study
Official title: Sirolimus Drug-eluting Stent for the Treatment of Infrapopliteal Peripheral Artery Disease: Evaluation of Safety and Performance in Everyday Clinical Practice. The Cre8™ BTK Post Market Clinical Follow-up Study.
Cre8™ BTK is a CE marked drug eluting stent, integrally coated with i-Carbofilm, loaded with formulated Sirolimus for the treatment of infrapopliteal peripheral artery disease.
The aim of this post-market retrospective study protocol P32102 is to collect clinical data of patient treated with Cre8™ BTK stent 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 the Cre8™ BTK stent at least 12 months prior to the study start.
Read the detailed description
The objective of this post-market observational study is to collect retrospective clinical data on the implantable medical device Cre8™ BTK in an unselected population, in the current clinical practice treated within the intended use. Data will be collected via medical chart review in anonymous form to assess the safety and efficacy of the device.
The Cre8™ BTK stent is made of cobalt-chromium alloy (L605) and it is coated with iCarbofilm™, a thin carbon film with a high density turbostratic structure substantially identical with that of the pyrolytic carbon used for mechanical cardiac valve discs. Coating the substrate with iCarbofilm™ provides it with the bio- and haemocompatible characteristics of pyrolytic carbon, without affecting the physical and structural properties of the substrate itself. The outer surface of the stent has dedicated grooves, fully coated with iCarbofilm™, for containing the pharmaceutical formulation Amphilimus™, which is composed of the drug sirolimus and a mixture of long-chain fatty acid.
The specific drug dosage is 0.9 μg/mm2 corresponding to a minimum dose of 50 μg on the smaller stent (2.25x8mm) and a maximum dose of 395 μg on the larger stents (4.0x38mm and 3.5x46mm). Two radiopaque platinum markers, positioned at each end of the stent, allow to correctly position it over the lesion to be treated.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Cre8™ BTK
- 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.
Cre8™ BTKDevice
Implant of Cre8™ BTK stent the treatment of infrapopliteal peripheral 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 start12 Apr 2023
- Primary completion24 Nov 2023
- Study completion31 Jan 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
- 30 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
- NCT05616156
- Sponsor's protocol ID
- P32102
- 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
- Sirolimus Drug-eluting Stent for the Treatment of Infrapopliteal Peripheral Artery Disease: Evaluation of Safety and Performance in Everyday Clinical Practice. The Cre8™ BTK Post Market Clinical Follow-up Study.
- ClinicalTrials.gov ID
- NCT05616156
- Acronym / sponsor ID
- P32102
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CID S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 31 Jan 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.
Cre8™ BTK is a CE marked drug eluting stent, integrally coated with i-Carbofilm, loaded with formulated Sirolimus for the treatment of infrapopliteal peripheral artery disease.
The aim of this post-market retrospective study protocol P32102 is to collect clinical data of patient treated with Cre8™ BTK stent 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 the Cre8™ BTK stent at least 12 months prior to the study start.
Detailed description
The objective of this post-market observational study is to collect retrospective clinical data on the implantable medical device Cre8™ BTK in an unselected population, in the current clinical practice treated within the intended use. Data will be collected via medical chart review in anonymous form to assess the safety and efficacy of the device.
The Cre8™ BTK stent is made of cobalt-chromium alloy (L605) and it is coated with iCarbofilm™, a thin carbon film with a high density turbostratic structure substantially identical with that of the pyrolytic carbon used for mechanical cardiac valve discs. Coating the substrate with iCarbofilm™ provides it with the bio- and haemocompatible characteristics of pyrolytic carbon, without affecting the physical and structural properties of the substrate itself. The outer surface of the stent has dedicated grooves, fully coated with iCarbofilm™, for containing the pharmaceutical formulation Amphilimus™, which is composed of the drug sirolimus and a mixture of long-chain fatty acid.
The specific drug dosage is 0.9 μg/mm2 corresponding to a minimum dose of 50 μg on the smaller stent (2.25x8mm) and a maximum dose of 395 μg on the larger stents (4.0x38mm and 3.5x46mm). Two radiopaque platinum markers, positioned at each end of the stent, allow to correctly position it 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 with infrapopliteal ischemic obstruction, implanted with at least one Cre8™ BTK drug eluting stent 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 Cre8™ BTK device 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 |
|---|---|---|
| Cre8™ BTKImplant of Cre8™ BTK stent the treatment of infrapopliteal peripheral 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
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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.
2 sites 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 2 sites 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 2 sites 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.