NCT02869087

The DESappear Study: Drug Eluting Scaffold

DESappear Study: Drug Eluting Scaffold With an Absorbable Platform for Primary Lower Extremity Arterial Revascularization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Elixir Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system for the treatment of symptomatic primary atherosclerotic stenoses and occlusions of the superficial femoral artery (SFA).

Detailed description

This is a mutli center, prospective ,single arm study enrolling up to 60 patients at up to 12 centers in New Zealand and Europe. The purpose is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus eluting bioresorbable scaffold system in peripheral arterial disease (PAD) Patients will be treated with the investigational device and followed up clinically at 1 month, 6 Months, 12 months, 24 months and 36 months post procedure. Patients will undergo non-invasive assessments such as Duplex Ultrasound (DUS), Ankle/Brachial Index (ABI) measurements and will complete a Walking Impairment Questionnaire (WIQ) and Quality of Life Questionnaire (VASCUQoL) at each follow up interval. Data will be collected via electronic data capture (EDC) and reportable Events will be reviewed by a medical monitor and classified using the MedDRA system. The information entered by the research centres will be source data verified (monitored) by an independent Contract Research Organisation (CRO.) A Data Monitoring Committee (DMC) with appropriately qualified members independent of the study will meet to review and adjudicate on events at predetermined intervals, according to the charter. Primary safety and efficacy endpoints will be evaluated at 6 months There will be no formal hypothesis testing in the study, endpoints will be evaluated with 95% confidence intervals around the observed point estimates. The endpoints will be evaluated with Kaplan-Meier methodology.

Conditions

• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Akesys Prava Scaffold	Implantation of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral Scaffold System

Timeline

• Start date: 2016-10-10
• Primary completion: 2018-08-28
• Completion: 2021-04-30
• First posted: 2016-08-16
• Last updated: 2021-06-01

Locations

11 sites across 4 countries: Austria, Belgium, Germany, New Zealand