The Cre8™ BTK Post Market Clinical Follow-up Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Cre8™ BTK

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Franco Vallana, MD; Phone Number: +39 0161 18261; Email: franco.vallana@alvimedica.com

Study Locations

• Italy
  • Reggio Calabria, Italy
    • Grande Ospedale Metropolitano Bianchi Melacrino Morelli
    • Contact: Pietro Volpe, MD
  • Padova
    • Abano Terme, Padova, Italy
      • Pliclinico Abano terme
      • Contact: Marco Manzi, MD; Email: marcodocmanzi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 patency	Patency following successful target lesion revascularization (TLR)	6 months and 12 months or latest patency data available
Death	Death within 30 days of the index procedure	30 days
Clinically driven Target Lesion Revascularization	Clinically driven Target Lesion Revascularization	6 months and 12 months
Target limb ischemia	Target limb ischemia requiring surgical intervention or surgical repair of target vessel rate	6 months and 12 months
Rutherford category measurement	Rutherford category measurement	pretreatment, 6 months and 12 months
Evaluation of Serious Adverse Events (SAEs)	Evaluation of Serious Adverse Events (SAEs)	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	24/72 hours

Collaborators and Investigators

• Sponsor: CID S.p.A.
• Collaborators: Meditrial Europe Ltd.

Publications and helpful links

Helpful Links

• Manufactured website
• Clinical Research Organization

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: P32102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No