NCT04562805

Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)

Infinity-Swedeheart Study: Registry Based Randomized Clinical Trial (R-RCT) Comparing Long Term Outcomes of the DynamX Bioadaptor to the Resolute Onyx Stent in a More-comer PCI Patient Population

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,400 (estimated)
• Sponsor: Elixir Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The Infinity-Swedeheart trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. Eligible patients will be randomized 1:1 (DynamX Bioadaptor : Resolute Onyx).

Detailed description

The Infinity-Swedeheart trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. Eligible patients will be randomized 1:1 (DynamX Bioadaptor : Resolute Onyx). 2400 Patients will be randomized in Sweden. Patients will be followed at 30 days and 1 year by phone, and at 6 months and 2 to 5 years through clinical and diagnostic registries.

Conditions

• Coronary Artery Disease
• Ischemic Heart Disease

Interventions

Type	Name	Description
DEVICE	DynamX Bioadaptor	DynamX Bioadaptor Treatment
DEVICE	Resolute Onyx	Resolute Onyx Treatment

Timeline

• Start date: 2020-09-30
• Primary completion: 2024-09-05
• Completion: 2028-07-31
• First posted: 2020-09-24
• Last updated: 2024-10-16

Locations

19 sites across 1 country: Sweden

Regulatory

• FDA-regulated device study