Coronary Artery DiseaseNCT00792753
Elixir Medical Clinical Evaluation of the Novolimus-Eluting Coronary Stent System: A Randomized Study "EXCELLA II STUDY"
A study testing Medtronic Endeavor Coronary Stent System, DESyne BD Novolimus Stent System and DESyne Novolimus Stent System in people with Coronary Artery Disease, run by Elixir Medical Corporation at 8 sites in 8 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Medtronic Endeavor Coronary Stent System, DESyne BD Novolimus Stent System and DESyne Novolimus Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Oct 2008to 8 Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Medtronic Endeavor Coronary Stent System, DESyne BD Novolimus Stent System, DESyne Novolimus Stent System
- Keywords
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Endeavor Coronary Stent SystemDevice
coronary stent implantation
DESyne BD Novolimus Stent SystemDevice
coronary stent implantation
DESyne Novolimus Stent SystemDevice
coronary stent implantation
| Study group | Role | What they receive |
|---|---|---|
| 1. DESyne DES | Experimental | Test arm: Intervention with DESyne Novolimus-Eluting Coronary Stent DESyne Novolimus Stent System Receives: Device: DESyne Novolimus Stent System |
| 2. Medtronic Endeavor DES | Active comparator | Control arm: Intervention with Medtronic Endeavor Zotarolimus-Eluting Coronary Stent Medtronic Endeavor Coronary Stent System Receives: Device: Medtronic Endeavor Coronary Stent System |
| 3. DESyne BD DES | Experimental | Test arm: Intervention with DESyne BD Novolimus-Eluting Coronary Stent DESyne BD Novolimus Stent System Receives: Device: DESyne BD Novolimus Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent late lumen loss assessed by QCA
Measured: 9 months
Secondary outcomes (1)
Device-oriented Composite Endpoints
Measured: 1, 6, 9, and 12 months and annually to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2011
- Study completion8 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elixir Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick W Serruys, MD, PhD, Principal investigator, Thoraxcentrum, Rotterdam, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792753
- Sponsor's protocol ID
- ELX-CL-0801
- Status last verified
- Apr 2020
- First submitted
- 14 Nov 2008
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Iqbal J, Verheye S, Abizaid A, Ormiston J, de Vries T, Morrison L, Toyloy S, Fitzgerald P, Windecker S, Serruys PW. DESyne novolimus-eluting coronary stent is superior to Endeavor zotarolimus-eluting coronary stent at five-year follow-up: final results of the multicentre EXCELLA II randomised controlled trial. EuroIntervention. 2016 Dec 10;12(11):e1336-e1342. doi: 10.4244/EIJY15M10_04.
PubMed 26465374
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00792753
- Acronym / sponsor ID
- ELX-CL-0801
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Elixir Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- 8 Mar 2014 (actual)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. DESyne DES | Experimental | Device: DESyne Novolimus Stent SystemTest arm: Intervention with DESyne Novolimus-Eluting Coronary Stent DESyne Novolimus Stent System |
| 2. Medtronic Endeavor DES | Active comparator | Device: Medtronic Endeavor Coronary Stent SystemControl arm: Intervention with Medtronic Endeavor Zotarolimus-Eluting Coronary Stent Medtronic Endeavor Coronary Stent System |
| 3. DESyne BD DES | Experimental | Device: DESyne BD Novolimus Stent SystemTest arm: Intervention with DESyne BD Novolimus-Eluting Coronary Stent DESyne BD Novolimus Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Endeavor Coronary Stent Systemcoronary stent implantation | Device | 2. Medtronic Endeavor DES |
| DESyne BD Novolimus Stent Systemcoronary stent implantation | Device | 3. DESyne BD DES |
| DESyne Novolimus Stent Systemcoronary stent implantation | Device | 1. DESyne DES |
Primary outcome
In-stent late lumen loss assessed by QCA
Time frame: 9 months
1 secondary outcome
Device-oriented Composite Endpoints
Time frame: 1, 6, 9, and 12 months and annually to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Results publication: PubMed 26465374Iqbal J, Verheye S, Abizaid A, Ormiston J, de Vries T, Morrison L, Toyloy S, Fitzgerald P, Windecker S, Serruys PW. DESyne novolimus-eluting coronary stent is superior to Endeavor zotarolimus-eluting coronary stent at five-year follow-up: final results of the multicentre EXCELLA II randomised controlled trial. EuroIntervention. 2016 Dec 10;12(11):e1336-e1342. doi: 10.4244/EIJY15M10_04.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick W Serruys, MD, PhD principal investigator
Thoraxcentrum, Rotterdam, Netherlands
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Endeavor Coronary Stent System, DESyne BD Novolimus Stent System and DESyne Novolimus Stent System in people with Coronary Artery Disease, run by Elixir Medical Corporation at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, Belgium, Brazil, Germany, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent late lumen loss assessed by QCA (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00792753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.