Elixir Medical Clinical Evaluation of the Novolimus-Eluting Coronary Stent System: A Randomized Study "EXCELLA II STUDY"

April 6, 2020 updated by: Elixir Medical Corporation

A Randomized, Single Blind, Consecutive Enrollment Evaluation of the Elixir Novolimus-Eluting Coronary Stent System With Durable Polymer Compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System in the Treatment Of Patients With De Novo Native Coronary Artery Lesions And A Randomized, Consecutive Enrollment Evaluation of the Elixir Novolimus-Eluting Coronary Stent System With Bioabsorbable Polymer Compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System in the Treatment Of Patients With De Novo Native Coronary Artery Lesions

Randomized Study To evaluate the safety and effectiveness of the Elixir Medical DESyne Novolimus-Eluting Coronary Stent System with Durable Polymer through the assessment of clinical, angiographic and IVUS endpoints as compared to the concurrently enrolled Medtronic Zotarolimus-Eluting Coronary Stent System in a randomized, single blind study of up to 200 male and female patients. In a Continued Access Registry of up to 100 patients receiving the DESyne Stent clinical-only endpoints will be evaluated.

To evaluate the safety and effectiveness of the Elixir Novolimus-Eluting Coronary Stent System with bioabsorbable polymer as compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System control through clinical and angiographic endpoints.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, 3168
        • Monash Medical Center
  • Belgium
      • Gent, Belgium, 9000
        • University Hospital Gent
  • Brazil
      • Sao Paulo, Brazil, 0401210
        • Instituto Dante Pazzanese
  • Germany
      • Hamburg, Germany, 22527
        • Universitäres Herz- und Gefäßzentrum
  • Netherlands
      • Rotterdam, Netherlands, 3015
        • Thoraxcentrum
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
  • Poland
      • Krakow, Poland, 31-501
        • Jagiellonian University
  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient has a planned intervention of a single lesion in one or two separate major epicardial territories. Each lesion/vessel must meet the following criteria:
  • De novo
  • The target lesion reference site must be visually estimated to be > 2.5 mm and < 3.5 mm in diameter.
  • The target vessel must be a major coronary artery or major branch with a visually estimated stenosis of > 50% and <100%.
  • The visually estimated target lesion must be able to be covered by a single, 14, 18 or 28mm stent Elixir Stent or a single 14, 18, 24 or 30mm Endeavor Stent. Note that the 8mm Endeavor Stent will not be used in this study.
  • Maximum lesion length is 24 mm.
  • > TIMI 1 coronary flow.

Exclusion Criteria:

  • The patient has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, mTOR inhibitor class drugs, cobalt chromium alloy, methacrylate or polylactide polymer, or sensitivity to contrast which cannot be adequately premedicated.
  • There will be an untreated significant lesion of > 40% diameter stenosis remaining proximal or distal to the target site after the planned intervention.
  • Total occlusion or TIMI 0 coronary flow in the target vessel.
  • Restenosis lesion
  • The proximal target vessel or target lesion is severely calcified by visual assessment.
  • Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the LAD or LCX.
  • Lesion involvement of a significant side branch (branch diameter > 2 mm) that would be covered by stenting.
  • The patient has suffered a myocardial infarction with total creatine kinase (CK) >2 times normal within the past 72 hours (exactly three days).
  • The patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • The patient suffered a stroke, transient ischemic neurological attack (TIA) or significant gastrointestinal (GI) bleed within the past six months.
  • The patient has renal insufficiency as determined by a creatinine of > 2.0mg/dl.
  • The target lesion, or the target vessel proximal to the target lesion, contains thrombus.
  • Documented left ventricular ejection fraction of < 25%.
  • The patient is a recipient of a heart transplant.
  • The patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion or extreme anti-coagulation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1. DESyne DES
Test arm: Intervention with DESyne Novolimus-Eluting Coronary Stent DESyne Novolimus Stent System
Device: DESyne Novolimus Stent System
coronary stent implantation
ACTIVE_COMPARATOR: 2. Medtronic Endeavor DES
Control arm: Intervention with Medtronic Endeavor Zotarolimus-Eluting Coronary Stent Medtronic Endeavor Coronary Stent System
Device: Medtronic Endeavor Coronary Stent System
coronary stent implantation
EXPERIMENTAL: 3. DESyne BD DES
Test arm: Intervention with DESyne BD Novolimus-Eluting Coronary Stent DESyne BD Novolimus Stent System
Device: DESyne BD Novolimus Stent System
coronary stent implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-stent late lumen loss assessed by QCA
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Device-oriented Composite Endpoints
Time Frame: 1, 6, 9, and 12 months and annually to 5 years
1, 6, 9, and 12 months and annually to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elixir Medical Corporation

Investigators

  • Principal Investigator: Patrick W Serruys, MD, PhD, Thoraxcentrum, Rotterdam, Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

March 8, 2014

Study Registration Dates

First Submitted

November 14, 2008

First Submitted That Met QC Criteria

November 17, 2008

First Posted (ESTIMATE)

November 18, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELX-CL-0801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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