The Cre8™ BTK Post Market Clinical Follow-up Study

Peripheral Arterial Disease Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05616156
• Other study ID #: P32102
• Status: Not yet recruiting
• Start date: February 2023
• Est. completion date: July 2023

Study information

• Verified date: November 2022
• Source: CID S.p.A.
• Contact: Franco Vallana, MD
• Phone: +39 0161 18261
• Email: franco.vallana[@]alvimedica.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Cre8™ BTK
Implant of Cre8™ BTK stent the treatment of infrapopliteal peripheral artery disease

Locations

Country	Name	City	State
Italy	Pliclinico Abano terme	Abano Terme	Padova
Italy	Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria

Sponsors (2)

Lead Sponsor	Collaborator
CID S.p.A.	Meditrial Europe Ltd.

Country where clinical trial is conducted

Italy, 

Outcome

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

External Links

•   Clinical Research Organization
•   Manufactured website