- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02765646
eTryton Left Main Registry Tryton Side Branch Stent® Tmt of Denovo CAD in LM and CFX Arteries (eTRYTONLM)
April 25, 2019 updated by: Tryton Medical, Inc.
eTryton Left Main Multi-center, Prospective, Non-randomized Single Arm Registry Evaluating the Tryton Side Branch Stent® for Treatment of de Novo CAD in Both LM and Circumflex (LCX) Coronary Arteries
The objective of this study is to demonstrate the clinical performance of the Tryton Side Branch Stent used in conjunction with a commercially available Drug Eluting Stent (DES) to treat de novo bifurcated lesions involving both the Left Main (LM) and Circumflex Coronary Artery(LCX).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The registry study will involve the collection of demographic and clinical data, including in-hospital and follow-up data to determine primary composite endpoint of MACE (Major Adverse Cardiac Events) at 9 months and secondary endpoints.
Secondary endpoints are defined as successful deployment of the Tryton stent and main vessel DES within the target lesion, angiographic success <30% residual stenosis in LM and LAD/LCX by visual estimate and TIMI 3 flow post procedure, and freedom of in-hospital MACE.
Study Type
Observational
Enrollment (Anticipated)
100
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
-
-
-
Coburg, Germany, 96450
- Klinikum Cobury GmbH
-
-
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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with CAD due to de novo stenotic lesion in the distal part of the LM at the bifurcation of the Left Anterior Descending Artery (LAD) and the Left Circumflex (LCX)
Description
Inclusion Criteria:
- Patient is ≥18 years old;
- Patient is eligible for percutaneous coronary intervention (PCI);
- Patient is an acceptable candidate for CABG;
- Clinical evidence of ischemic heart disease and / or a positive functional registry. Documented stable angina pectoris (Canadian cardiovascular society classification (CCS) 1, 2, 3 or 4), unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia;
- Single high grade de novo bifurcation lesion with ≥50% and <100% stenosis in the distal part of left main, requiring stent placement across LCx Ostium, with TIMI flow > 2 by visual estimation;
- The target lesion length must be able to be covered by a single main vessel stent ≥ 5.0mm and ≤ 32 mm in the main vessel and ≤ 32 mm in the side branch (visual estimate) and be covered by one Tryton stent and up to one DES in the side branch;
- The reference vessel diameter of the main branch must be ≥ 2.5mm and ≤ 4.0 mm (visual estimate) and reference vessel diameter of the side branch must be ≥ 2.25mm and ≤ 3.5 mm (visual estimate);
- If required by local regulations, the patient had been informed of the nature of the registry, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC) of the respective clinical site;
- The patient is willing to comply with follow-up evaluations.
Exclusion Criteria:
- Female of childbearing potential;
- Documented left ventricular ejection fraction (LVEF) ≤30%;
- Evidence of an acute myocardial infarction within 48 hours of the intended treatment;
- Known allergies to the following: Acetylsalicylic acid (ASA) (Aspirin®), Clopidogrel bisulfate (Plavix®.) or Ticlopidine (Ticlid®.), Heparin, contrast agent (that cannot be adequately pre-medicated);
- Acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or >150μmol/L);
- Target vessel has angiographic evidence of thrombus;
- Previous interventional procedure (less than 1 year) anywhere within the left main artery including the bifurcation to the LAD and/or LCX;
- Anticipated use of rotational atherectomy
- Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run offCONFIDENTIAL Page 7 of 18 August 11, 2015 - version 5 that will not be treated during the index procedure;
- Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
- Prior stent in the Left Main;
- Prior stent within 5mm distal of the target lesion;
- Total occluded dominant RCA;
- Trifurcation lesion with a Ramus Intermedius diameter of >2.0 mm; a Diagonal Branch diameter of >2.0 mm within 5 mm of LAD origin; a Obtuse Marginal >2.0 mm diameter within 5 mm of LCx origin;
- Patient is currently participating in an investigational drug or device registry that has not completed the primary endpoint or that clinically interferes with the current registry endpoints.
- Stroke or transient ischemic attack within the prior 6 months;
- In the Investigator's opinion patient has a co-morbid condition(s) that could limit the patient's ability to participate in the registry, compliance with follow-up requirements or impact the scientific integrity of the registry;
- Recipient of heart transplant;
- Life expectancy less than 1 year;
- Braunwald Class IA, IIA and IIA angina pectoris;
- Patients with severe congestive heart failure;
- Patients with severe heart failure NYHA IV;-
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MACE: cardiac death, non-index procedure related myocardial infarction, TLR, definite stent thrombosis
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Procedural success: successful deployment of Tryton stent and MV DES within target lesion, Angiographic success <30% residual stenosis in LM and LAD/LCX bifurcation by visual est. and TIMI flow 3 post procedure and freedom of in-hospital MACE
Time Frame: 9 months
|
9 months
|
Clinical endpoints: MACE: total death, cardiac death, non-index procedure related MI, Target lesion revascularization (TLR), Target vessel revascularization (TVR), definite stent thrombosis, Procedure related MI
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stylianos A Pyxaras, MD,FESC, Klinikum-Coburg, Germany
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
May 1, 2016
Primary Completion (Anticipated)
June 1, 2019
Study Completion (Anticipated)
August 1, 2019
Study Registration Dates
First Submitted
May 3, 2016
First Submitted That Met QC Criteria
May 5, 2016
First Posted (Estimate)
May 6, 2016
Study Record Updates
Last Update Posted (Actual)
April 26, 2019
Last Update Submitted That Met QC Criteria
April 25, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P0160
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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.
Clinical Trials on Left Main Coronary Artery Stenosis
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Medical University of SilesiaCompletedLeft Main Coronary Artery Disease | Restenosis, Coronary | PTCA Left Main Artery ComplicationsPoland, Italy
-
ECRI bvBoston Scientific Corporation; Philips HealthcareActive, not recruitingLeft Main Coronary Artery StenosisSpain, United Kingdom, Italy
-
Institut Mutualiste MontsourisCompletedLeft Main Coronary Artery StenosisFrance
-
Fundación Pública Andaluza Progreso y SaludUnknownUnprotected Left Main Coronary Artery StenosisSpain
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingHeart Diseases | Coronary Artery Disease | Heart Valve Diseases | Carotid Stenosis | Left Main Coronary Artery Disease | Left Anterior Descending Coronary Artery Stenosis | Valve Disease, Heart | Carotid OcclusionItaly
-
Université de SherbrookeWithdrawnLeft Main Coronary Artery Disease | StenosisCanada
Clinical Trials on Coronary stent procedure (CSP)
-
Fundación Pública Andaluza Progreso y SaludUnknownUnprotected Left Main Coronary Artery StenosisSpain
-
Medinol Ltd.CompletedIschemic Heart DiseaseIsrael, Sweden, Belgium, Germany
-
Odense University HospitalCompletedIschemic Heart Disease | Percutaneous Coronary Intervention | Coronary AtherosclerosisDenmark
-
Abbott Medical DevicesCompleted
-
A.O. Ospedale Papa Giovanni XXIIIMedtronic; Case Western Reserve UniversityCompletedAcute Myocardial InfarctionItaly
-
Palmaz ScientificClinLogix. LLCCompleted
-
CCRF Consulting Co., Ltd.Peking University First Hospital; Terumo Medical(shanghai) Co.,Ltd.UnknownFree Rate of Cardiac or Cerebrovascular Events | Transradial-transfemoral Coronary Interventions ComparisonChina
-
BioSync Scientific Pvt. Ltd.Cardialysis BV; MIV Therapeutics Inc.UnknownCoronary Artery Disease
-
Rigshospitalet, DenmarkCompleted
-
Russian Academy of Medical SciencesMedtronicUnknownST Elevation Myocardial Infarction, Multivessel Coronary Artery DiseaseRussian Federation