Clinical trial NCT05616156: The Cre8™ BTK Post Market Clinical Follow-up 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Lead sponsor: CID S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Meditrial Europe Ltd.
First posted: 2022-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients treated less than 12 months prior to study start

Primary outcomes:
measure: Rate of Major Adverse Events (MAE)
timeFrame: 12 months
Secondary outcomes:
measure: Primary patency
timeFrame: 6 months and 12 months
measure: Limb-salvage rate (LSR)
timeFrame: 6 months and 12 months
measure: Secondary patency
timeFrame: 6 months and 12 months or latest patency data available
measure: Death
timeFrame: 30 days
measure: Clinically driven Target Lesion Revascularization
timeFrame: 6 months and 12 months
measure: Target limb ischemia
timeFrame: 6 months and 12 months
measure: Rutherford category measurement
timeFrame: pretreatment, 6 months and 12 months
measure: Evaluation of Serious Adverse Events (SAEs)
timeFrame: 6 months and 12 months
measure: Acute success (device and procedural) within discharge
timeFrame: 24/72 hours
Other outcomes:
Locations:
city: Abano Terme
country: Italy
facility: Pliclinico Abano terme
state: Padova
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Study officials:
References: