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Elixir Medical Clinical Evaluation of the DESolve Myolimus Eluting Bioresorbable Coronary Stent System - DESolve I Trial

NCT02086006 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-09-07

No results posted yet for this study

Summary

This prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with single de novo, Type A lesions \< 10 mm in length and located in a native coronary artery with a reference vessel diameter of 2.75 mm - 3.0 mm as measured by both offline QCA and IVUS. All patients will receive a 3.0 x 14mm DESolve Stent loaded with approximately 40 mcg of Myolimus.

* Angiographic and intravascular ultrasound (IVUS) will be completed for all patients at baseline and at 6 months.
* Optical Coherence Tomography (OCT) will will be completed for all patients at baseline and at 6 months.
* Multi-slice computed tomography (MSCT) will be conducted on all patients enrolled at 12 and 24 months.

Conditions

Interventions

DEVICE

DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

Sponsors & Collaborators

  • Elixir Medical Corporation

    lead INDUSTRY

Principal Investigators

  • John Ormiston, MD · Auckland City Hospital and Mercy Angiography Unit

  • Stefan Verheye, MD, PhD · ZNA Middelheim

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2016-10-31
Completion
2017-04-30

Countries

  • Belgium
  • 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 NCT02086006 on ClinicalTrials.gov