Left Main Coronary Artery StenosiseTRYTONLMNCT02765646
eTryton Left Main Registry Tryton Side Branch Stent® Tmt of Denovo CAD in LM and CFX Arteries
An observational study of Left Main Coronary Artery Stenosis, run by Tryton Medical, Inc. at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Left Main Coronary Artery Stenosis
- What is being tested?
- Coronary stent procedure (CSP)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Aug 2019
- How long will I take part?
- 9 Months
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Left Main Coronary Artery Stenosis
- Being tested
- Coronary stent procedure (CSP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary stent procedure (CSP)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE: cardiac death, non-index procedure related myocardial infarction, TLR, definite stent thrombosis
Measured: 9 months
Secondary outcomes (2)
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
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Main Coronary Artery StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Tryton Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stylianos A Pyxaras, MD,FESC, Principal investigator, Klinikum-Coburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765646
- Sponsor's protocol ID
- P0160
- Acronym
- eTRYTONLM
- Status last verified
- Apr 2019
- First submitted
- 3 May 2016
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02765646
- Acronym / sponsor ID
- eTRYTONLM / P0160
- Conditions
- Left Main Coronary Artery Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tryton Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 6 May 2016 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (22 listed)
- 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);
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 |
|---|---|---|
| Coronary stent procedure (CSP) | Device | – |
Primary outcome
MACE: cardiac death, non-index procedure related myocardial infarction, TLR, definite stent thrombosis
Time frame: 9 months
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Stylianos A Pyxaras, MD,FESC principal investigator
Klinikum-Coburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Main Coronary Artery Stenosis, run by Tryton Medical, Inc. at 1 site in Germany.
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 9 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
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?
MACE: cardiac death, non-index procedure related myocardial infarction, TLR, definite stent thrombosis (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2019.