NCT04483791

DynamX Bioadaptor Hong Kong Registry

A Non-Randomized, Clinical Registry of the Dynamx Novolimus Eluting Coronary Bioadaptor System in the Treatment of Patients With De Novo Native Coronary Artery Lesions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Elixir Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prospective, non-randomized, multicenter registry

Detailed description

Enrollment of up to 50 subjects with up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and\<=34 mm in length receiving the DynamX Novolimus Eluting Coronary Bioadaptor System (CSS), with primary, interim clinical follow-up via telephone at 1 month. Follow-up will continue at 6, and 12 months. to capture cardiovascular related hospitalizations related to the study devic

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
COMBINATION_PRODUCT	DynamX Novolimus Eluting Coronary Bioadaptor System	up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and\<=34 mm in length receiving the DynamX Novolimus Eluting Coronary Bioadaptor System

Timeline

• Start date: 2020-09-30
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-07-23
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

4 sites across 1 country: China