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DynamX Sirolimus Study Sirolimus Eluting Coronary Bioadaptor System

NCT03634020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-04-26

No results posted yet for this study

Summary

To confirm the safety and performance of the DynamX Sirolimus-eluting Coronary Bioadaptor System (SECBS) in de novo native coronary artery lesions using clinical and imaging endpoints. Clinical follow-up will be conducted in all patients at 30 days, 6 and 12 months. Imaging follow-up will be conducted at 6 months.

Conditions

Interventions

DEVICE

DynamX Sirolimus-eluting Coronary Bioadaptor System

de novo native coronary artery lesions

Sponsors & Collaborators

  • Elixir Medical Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2021-03-08
Completion
2021-03-08
FDA Device
Yes

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03634020 on ClinicalTrials.gov