NCT02793349

The ABSORB Bioresorbable Scaffold Below the Knee (BTK) Study

ABSORB BTK Study: A Prospective, Multi-center, Controlled Clinical Evaluation of the Use of a Bioresorbable Drug Eluting Stent (Absorb, Abbott Vascular) in the Arterial Vasculature Below the Knee

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: The University of New South Wales · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

ABSORB BTK Study: A prospective, multicenter, controlled clinical evaluation of the use of a bioresorbable drug eluting stent in the arterial vasculature below the knee

Detailed description

The aim of this study is to evaluate the performance of a bioresorbable vascular scaffold (BVS) coated with the drug Everolimus. This will be used to treat short length blockages of up to 55mm (5.5cm) in arteries below the knee. This will be performed to treat patients who have severe leg pain or have developed skin ulcers or gangrene which are not healing due to insufficent blood supply. The ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold works on similar principles of drug eluting stents which have been used for a considerable time in treating blocked arteries. However this product consists of a scaffold coated with a drug so rather than leaving a metallic stent in the blood vessel, this product primarily delivers the drug, gives mechanical support to the blood vessel and once it is no longer needed the scaffold absorbs into the body leaving no permanent metallic implant. This same device has been used safely and effectively in the arteries which supply the heart both in clinical trials and current practice and has also been evaluated in the leg arteries in a single-centre pilot study. This study aims to evaluate it's use in a larger number of patients in multiple centres and compare that to a historical control group of metal drug eluting stents. The study will evaluate both ultrasound and angiographic derived patency in those arteries out to a 36 month follow-up time point. This data will be collected in patients who fulfill the inclusion criteria and who are then treated and followed over time.

Conditions

• Ischemia
• Peripheral Arterial Disease (PTA
• Arterial Occlusive Diseases

Interventions

Type	Name	Description
DEVICE	Absorb Bioresorbable Vascular Scaffold	Absorb Bioresorbable Vascular Scaffold

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-06-08
• Last updated: 2019-04-17

Locations

4 sites across 3 countries: Australia, Netherlands, New Zealand