NCT02470884

FAST Feasibility Study

Fully Absorbable Scaffold Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective multi-center, single arm feasibility study to assess the safety and performance of the Boston Scientific Fully Absorbable Scaffold.

Detailed description

The Boston Scientific Fully Absorbable Scaffold is a device/drug combination product providing a mechanical structure for vascular lumen support (the scaffold component) and a pharmacological agent (everolimus) targeted toward reducing the injury response that leads to restenosis after scaffold implantation. The Boston Scientific Fully Absorbable Scaffold is intended to improve the luminal diameter in subjects with ischemic heart disease due to de novo native coronary artery target lesions ≤ 12 mm in length with reference vessel diameter ≥ 2.75 mm and ≤ 3.25 mm. Subjects who are candidates for PCI for the treatment of a de novo native coronary artery lesion will be screened according to the protocol inclusion and exclusion criteria. Subjects will be considered enrolled once they have signed the informed consent form and an attempt has been made to implant the fully absorbable study scaffold. During the index procedure 1 target lesion in a de novo native coronary artery may be treated. Up to 1 non-target lesion in a separate epicardial vessel may be treated with a commercially approved DES

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Boston Scientific Fully Absorbable Scaffold	Attempt to implant the Boston Scientific Fully Absorbable Scaffold.

Timeline

• Start date: 2015-06-15
• Primary completion: 2017-01-31
• Completion: 2022-02-02
• First posted: 2015-06-12
• Last updated: 2022-06-22

Locations

7 sites across 3 countries: Australia, Latvia, New Zealand