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eTryton Left Main Registry Tryton Side Branch Stent® Tmt of Denovo CAD in LM and CFX Arteries | Clinical Trials | Clareo Health

UNKNOWN

eTryton Left Main Registry Tryton Side Branch Stent® Tmt of Denovo CAD in LM and CFX Arteries

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

NCT02765646•Tryton Medical, Inc.

View on ClinicalTrials.gov

Summary

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).

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Patient is ≥18 years old;
•2. Patient is eligible for percutaneous coronary intervention (PCI);
•3. Patient is an acceptable candidate for CABG;
•4. 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;
•5. 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;
•6. 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;
•7. 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);
•8. 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;
•9. The patient is willing to comply with follow-up evaluations.

Exclusion Criteria

•1. Female of childbearing potential;
•2. Documented left ventricular ejection fraction (LVEF) ≤30%;
•3. Evidence of an acute myocardial infarction within 48 hours of the intended treatment;
•4. Known allergies to the following: Acetylsalicylic acid (ASA) (Aspirin®), Clopidogrel bisulfate (Plavix®.) or Ticlopidine (Ticlid®.), Heparin, contrast agent (that cannot be adequately pre-medicated);
•5. Acute or chronic renal dysfunction (serum creatinine \>2.0 mg/dl or \>150μmol/L);
•6. Target vessel has angiographic evidence of thrombus;
•7. Previous interventional procedure (less than 1 year) anywhere within the left main artery including the bifurcation to the LAD and/or LCX;
•8. Anticipated use of rotational atherectomy
•9. 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;
•10. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
+12 more criteria

Locations (1)

Klinikum Cobury GmbH

Coburg, Germany

Key Dates

Start Date

May 1, 2016

Primary Completion Date

June 1, 2019

Completion Date

August 1, 2019

Last Updated

April 26, 2019

Enrollment

100

ESTIMATED participants

Conditions

Left Main Coronary Artery Stenosis

Interventions

Coronary stent procedure (CSP)

DEVICE

Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR

NCT03767621

Coronary Artery DiseaseLeft Main Coronary Artery Stenosis+2 more

View study

COMPLETEDNA

The OPTIMAL Randomized Controlled Trial

NCT04111770

Left Main Coronary Artery Stenosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 26, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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