The Cre8™ BTK Post Market Clinical Follow-up Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Cre8™ BTK


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cre8™ BTK|Implant of Cre8™ BTK stent the treatment of infrapopliteal peripheral artery disease|

What is the study measuring?
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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 |