Coronary Artery DiseasePASNCT03318796
Tryton Post Approval Study (PAS) for the Tryton Side Branch Stent
A study testing Coronary Artery Stenting in people with Coronary Artery Disease, run by Tryton Medical, Inc. at 1 site in United States.
Trial summary
TRYTON Post Approval Study (PAS) of the Tryton Side Branch Stent Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary Artery Stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 30 Dec 2022
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria
- The patient must be ≥18 and ≤ 90 years of age;
- Acceptable candidate for CABG;
- The intention to treat the side branch of the target bifurcation based on angiographic evaluation
- The patient is willing to comply with specified follow-up evaluations;
- The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Institutional Review Board (IRB).
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- Planned use of FDA approved and commercially available drug-eluting stents (DES) for subject's index procedure Angiographic Inclusion Criteria
- a) Single de novo lesion in a bifurcation involving both the main branch and the side branch b) The bifurcation: main branch and side branch with a visual diameter stenosis ≥ 50% (Medina classification 1.1.1; 0.1.1; 1.0.1) by visual assessment;
- Target lesion located in a native coronary artery;
- a) Bifurcation lesion main branch reference vessel diameter must be ≥2.5 mm to ≤ 4.0 mm, and b) Side branch reference vessel diameter must be ≥2.5mm by visual estimate (≥2.25mm by QCA) and <3.5 mm by visual estimate (<3.25 mm by QCA);
- a) Bifurcation lesion main branch lesion length ≤ 28 mm and b) Side branch lesion length ≤ 5.0 mm (the ability to be treated with a single stent for both main and side branch);
- Target lesion ≥50% and <100% stenosed by visual estimate in both the main branch and side branch; -
Who cannot join
- General Exclusion Criteria
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
- Impaired renal function (serum creatinine >2. mg/dL or 150 μmol/l);
- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis);
- Presence of a heart transplant
- Known allergy to cobalt chromium
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- Hypersensitivity or contraindication to cobalt-chromium or structurally-related compounds, cobalt, chromium, nickel, or tungsten
- Anticipated use of rotational artherectomy
- Patient in whom the use of a drug eluting stent is contraindicted, e.g., who cannot receive the recommended dual anti-platelet (aspirin and an approved P2Y12 inhibitor) and/or anticoagulant therapy
- Angiographic Exclusion Criteria:
- Left main coronary artery disease (protected and unprotected);
- Trifurcation lesion;
- Totally occluded target vessels (TIMI flow 0 or 1);
- Moderate to Severely calcified target lesion(s);
- Highly calcified target lesion(s) requiring rotational atherectomy;
- Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
- Angiographic evidence of thrombus in the target lesion(s);
- Tryton Stent placement without angioplasty pre-dilatation of the main branch and side branch (i.e., direct stenting is contraindicated)
- Tryton Stent placement alone, without implantation of a main branch stent
- An untreated significant (>50%) stenosis proximal or distal in either the side branch or main branch;
- Impaired runoff in the treatment vessel with diffuse distal disease;
- Left ventricular ejection fraction (LVEF) 30% (LVEF must be obtained within 6 months prior to the index procedure); -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NC Heart and Vascular Research/UNC REX
Raleigh, North Carolina, 27607
Joel Schneider, M.D., 919-787-5380, joel.schneider@unchealth.unc.edu
About this study
TRYTON Post Approval Study (PAS) of the Tryton Side Branch Stent
Read the detailed description
The primary objective of this PAS is to assure the continued safety and effectiveness of the Tryton Side Branch Stent™ with main branch approved DES in the treatment of de novo native coronary artery bifurcation lesions with side branch diameter ranging from ≥2.5 mm to ≤3.5 mm and main branch diameter ranging from ≥2.5 mm to ≤4.0 mm.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary Artery Stenting
- Keywords
- Bifurcation lesions
- 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.
Coronary Artery StentingDevice
Interventional coronary artery stent placement in De novo bifurcation lesions of the MB \& SB
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Other | Coronary artery stenting of De novo bifurcation lesions MB \& SB Receives: Device: Coronary Artery Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure (TVF)
Composite of cardiac death, target vessel MI (Q and non-Qwave) clinically driven target vessel revascularization
Measured: 1 year
Secondary outcomes (8)
Device success
Attainment of <30% residual stenosis within the side branch without device malfunction
Measured: 48 hrs
Lesion success
Attainment of <30% residual stenosis using any percutaneous method
Measured: 48 hrs
Procedure success
Lesion success without the occurrence of in-hospital MACE
Measured: 48 hrs
Death
All-cause and cardiac mortality
Measured: 1 year
Myocardial infarction (MI)
Q wave and Non-Q wave
Measured: 1 year
CD-TLR
Clinically driven target lesion revascularization
Measured: 1 year
CD-TVR
Clinically driven target vessel revascularization
Measured: 1 year
Stent thrombosis
ARC definition of definite and probable
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start22 Jan 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single arm open label registry
- Masking
- None (open label)
- Enrolment
- 335 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tryton Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Schnieder, MD, Principal investigator, Rex Health; Raleigh NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318796
- Sponsor's protocol ID
- P-0161
- Acronym
- PAS
- Status last verified
- Feb 2019
- First submitted
- 2 Oct 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tryton Post Approval Study (PAS) for the Tryton Side Branch Stent
- ClinicalTrials.gov ID
- NCT03318796
- Acronym / sponsor ID
- PAS / P-0161
- Conditions
- Coronary Artery Disease
- Keywords
- Bifurcation lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 335 participants (estimated)
- Lead sponsor
- Tryton Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 24 Oct 2017 (actual)
- 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.
TRYTON Post Approval Study (PAS) of the Tryton Side Branch Stent
Detailed description
The primary objective of this PAS is to assure the continued safety and effectiveness of the Tryton Side Branch Stent™ with main branch approved DES in the treatment of de novo native coronary artery bifurcation lesions with side branch diameter ranging from ≥2.5 mm to ≤3.5 mm and main branch diameter ranging from ≥2.5 mm to ≤4.0 mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single arm open label registry
| Arm | Type | Receives |
|---|---|---|
| Interventional | Other | Device: Coronary Artery StentingCoronary artery stenting of De novo bifurcation lesions MB \& SB |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- General Inclusion Criteria
- The patient must be ≥18 and ≤ 90 years of age;
- Acceptable candidate for CABG;
- The intention to treat the side branch of the target bifurcation based on angiographic evaluation
- The patient is willing to comply with specified follow-up evaluations;
Key exclusion criteria (22 listed)
- General Exclusion Criteria
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
- Impaired renal function (serum creatinine >2. mg/dL or 150 μmol/l);
- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis);
- Presence of a heart transplant
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 Artery StentingInterventional coronary artery stent placement in De novo bifurcation lesions of the MB \& SB | Device | Interventional |
Primary outcome
Target Vessel Failure (TVF)
Time frame: 1 year
Composite of cardiac death, target vessel MI (Q and non-Qwave) clinically driven target vessel revascularization
8 secondary outcomes
Device success
Time frame: 48 hrs
Lesion success
Time frame: 48 hrs
Procedure success
Time frame: 48 hrs
Death
Time frame: 1 year
Myocardial infarction (MI)
Time frame: 1 year
CD-TLR
Time frame: 1 year
CD-TVR
Time frame: 1 year
Stent thrombosis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 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.
Joel Schnieder, MD principal investigator
Rex Health; Raleigh NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Artery Stenting in people with Coronary Artery Disease, run by Tryton Medical, Inc. at 1 site in United States.
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 12 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 Feb 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 United States. 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?
Contact Doug Ferguson (617-852-9565, dferguson@trytonmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Vessel Failure (TVF) (time frame: 1 year). 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 Feb 2019.