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

NCT00792753 | Completed DMC

• 1 other identifier: ELX-CL-0801
• Study Type: interventional
• Target: 360
• Locations: 8 countries
• Sites: 8

Brief 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 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

Keywords

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• In-stent late lumen loss assessed by QCA

  9 months

Secondary Outcomes (1)

• Device-oriented Composite Endpoints

  1, 6, 9, and 12 months and annually to 5 years

Study Arms (3)

1. DESyne DES

EXPERIMENTAL

Test arm: Intervention with DESyne Novolimus-Eluting Coronary Stent DESyne Novolimus Stent System

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

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

Device: DESyne BD Novolimus Stent System

Interventions

Medtronic Endeavor Coronary Stent System DEVICE

coronary stent implantation

2. Medtronic Endeavor DES

DESyne BD Novolimus Stent System DEVICE

coronary stent implantation

3. DESyne BD DES

DESyne Novolimus Stent System DEVICE

coronary stent implantation

1. DESyne DES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elixir Medical Corporation: lead

Study Sites (8)

Monash Medical Center

Melbourne, 3168, Australia

Location

University Hospital Gent

Ghent, 9000, Belgium

Location

Instituto Dante Pazzanese

São Paulo, 0401210, Brazil

Location

Universitäres Herz- und Gefäßzentrum

Hamburg, 22527, Germany

Location

Thoraxcentrum

Rotterdam, 3015, Netherlands

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Jagiellonian University

Krakow, 31-501, Poland

Location

University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 26465374 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Patrick W Serruys, MD, PhD

  Thoraxcentrum, Rotterdam, Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 18, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: March 8, 2014
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); NL (1); CH (1); BR (1); AU (1); DE (1); BE (1); NZ (1)