NCT01856088

DESTINY TRIAL (Inspiron x Biomatrix)

Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - Destiny Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Scitech Produtos Medicos SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to evaluate the effectiveness of stent Inspiron ™ sirolimus-eluting and coating the abluminal biodegradable stent Biomatrix Flex ™ lesions in native coronary arteries.

Detailed description

This is a study of non-inferiority, multicentre, prospective, randomized into two treatment arms: I) Inspiron ™ stent eluting sirolimus or II) ™ Biomatrix stent eluting biolimus. Are a total of 165 randomized patients. Patients will be followed for 60 months after the procedure. All new patients will be undergoing angiography for evaluation at 9 months. A subgroup of 60 patients will be evaluated with volumetric intravascular ultrasound at 9 months. Also, a subgroup of 21 patients will be evaluated with optical coherence tomography at the end of the index procedure and 9 months. It is anticipated that the total study duration is 72 months: 12 months to complete the admission of patients and 60 months of follow-up.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Inspiron Stent	stent implantation
DEVICE	Biomatrix Flex Stent	stent implantation

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-09-01
• Completion: 2019-03-21
• First posted: 2013-05-17
• Last updated: 2019-03-25

Locations

10 sites across 1 country: Brazil