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AzTrials

Coronary Artery DiseasePhase 1/2SAFE-TRYNCT01174433

Safety Study to Assess the FEasibility of Use of the TRYTON Bifurcation Coronary Stent System (SAFE-TRY)

A Phase 1/2 study testing Tryton in people with Coronary Artery Disease and Angioplasty, Transluminal, Percutaneous Coronary, run by University of Padova at 6 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the safety and feasibility of the use of the Tryton bifurcation coronary stent system for the treatment of single de novo bifurcation lesions in native coronary arteries. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tryton
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
6 sitesItaly
Study dates
Sep 2009to Jun 2012
Phase
Phase 1/2
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria
  • Candidate for percutaneous coronary intervention \& emergent coronary artery bypass graft surgery
  • Clinical evidence of ischemic heart disease or a positive functional study
  • Female patients of childbearing potential has negative pregnancy test within 7 days before trial procedure
  • Patient or patient's legal representative provided written informed consent
  • Patient agrees to comply with follow-up evaluations
Show all 10Show fewer
  • Angiographic Inclusion Criteria
  • Target lesion in a single de novo true bifurcation lesion (Medina classification Type 1.1.1; 1.0.1; 0.1.1; 0.0.1) involving a native coronary artery with reference vessel diameter for the proximal main of 2.5 - 5.0 mm, distal main of 2.5 - 5.0 mm, \& side branch RVD of 2.5 - 3.5 mm
  • Target lesion in main vessel has stenosis of > 50% and <100%
  • Syntax score < 32

Who cannot join

  • General Exclusion Criteria
  • Known hypersensitivity/contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum, or sensitivity to contrast media, which can't be adequately pre-medicated
  • Platelet count <100,000 cells/mm³ or >700,000 cells/mm³, or a white blood cell (WBC) count <3,000 cells/mm³ within 7 days prior to index procedure
  • Serum creatinine level >170 micromol/L within 7 days prior to index procedure
  • Evidence of acute MI within 72 hours of intended trial procedure (defined as: QWMI or NQWMI having CK enzymes >2X laboratory upper limit of normal in the presence of a confirming cardiac specific biomarker (Troponin I or T)
  • Previous stenting anywhere in target vessel
Show all 22Show fewer
  • Percutaneous coronary intervention (PCI) of non-target vessel within 30 days prior to procedure that results in any MAC(C)E event. If non target vessel stent is implanted within 72 hours prior to index procedure, 2 post procedural serial CK or CK-MB measurements must be below investigational site's upper limit of normal
  • PCI of non-target vessel within 24 hours prior to procedure
  • Planned PCI of the target vessel within 6 months post-procedure
  • During index procedure, target lesion requires treatment with device other than PTCA or cutting balloon prior to stent placement
  • Documented left ventricular ejection fraction (LVEF) <30% at most recent evaluation
  • History of stroke or transient ischemic attack (TIA) within prior 6 months
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within prior 6 months
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Concurrent medical condition with life expectancy <12 months
  • Currently participating in investigational drug or device trial that's not completed the primary endpoint or that clinically interferes with current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures.
  • Angiographic Exclusion Criteria
  • Target lesion located in native vessel with saphenous vein graft or left/right internal mammary artery (LIMA/RIMA) bypass
  • Target lesion has any of following characteristics:
  • Severely calcified
  • Evidence of thrombus
  • Syntax score ≥33

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Italy6 sites

  • Castelfranco Veneto's Hospital

    Castelfranco Veneto, 31033

  • Conegliano's Hospital

    Conegliano, 31015

  • Angel's Hospital

    Mestre, 30170

  • Mirano's Hospital

    Mirano, 30035

  • Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy

    Padua, 35128

  • Vicenza's Hospital

    Vicenza, 36100

Other trials in Italy

About this study

To assess the safety and feasibility of the use of the Tryton bifurcation coronary stent system for the treatment of single de novo bifurcation lesions in native coronary arteries.

Read the detailed description

Currently available stents were designed for straight lesions, optimised to provide scaffolding (coverage and radial strength) and ease of deliverability. In straight lesions, these stents have been shown to provide superb acute and long-term results. One lesion subset that continues to challenge the interventionalist is bifurcations lesions. A number of different strategies have been employed with standard stents to address bifurcation lesions each of which have significant limitations. Large contemporary registries characterising current stent usage in bifurcating lesions have demonstrated decreased procedural success with increased rates in restenosis and thrombosis (acute, subacute and delayed). The limitations of currently available stents have led groups to develop stents designed specifically to treat bifurcation lesions. The Tryton Side-Branch Stent Stent TM (Tryton Medical, Inc., Newton, MA, USA) is a balloon expandable cobalt chromium stent, designed specifically to treat bifurcation lesions.

The primary objective of this study is to evaluate the safety and feasibility of the use of the Tryton bifurcation coronary stent system for the treatment of single de novo bifurcation lesions in native coronary arteries with reference vessel diameters (RVD) for the proximal main vessel of 2.5 - 5.0 mm, distal main branch of 2.5 - 5.0 mm, and side branch RVD 2.5 - 3.5 mm.

Being tested
Tryton
Keywords
Bifurcation coronary artery disease, Percutaneous coronary intervention, Tryton Stent
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.

  • TrytonDevice

    Also called Tryton bifurcation stent system

    Percutaneous coronary intervention of a bifurcation lesion, with a Tryton bifurcation coronary stent for the side branch and a drug-eluting coronary stent for the main branch

Study groups in NCT01174433
Study groupRoleWhat they receive
Tryton bifurcation stent systemExperimentalNot described
Receives: Device: Tryton

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 30 days post procedure

    A composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 30 days post procedure.

    Measured: 30 days (plus or minus 3 days)

Secondary outcomes (6)

  1. Angiographic and Procedural success

    Acute device success, Technical Success, Clinical Procedural Success, Device malfunctions, Ease-of-Use parameters, Main branch and side branch angiographic endpoints, Main branch and side branch IVUS endpoints (Reference Lumen Area; Reference EEM Area; Lesion Lumen Area; Lesion EEM Area; Maximum Atheroma Thickness; Minimum Atheroma Thickness; Lesion Maximum Lumen Diameter; Lesion Minimum Lumen Diameter and derived Measurements; calcium measurement)

    Measured: 30 days (plus or minus 3 days)

  2. Total volume of contrast used

    Total volume of contrast used, in mL

    Measured: 24 hours

  3. Total index PCI procedure time

    Total index PCI procedure time, in minutes

    Measured: 24 hours

  4. Target vessel revascularization (TVR) rate

    Target vessel revascularization (TVR) rate, at 9 months

    Measured: 9 months

  5. Target lesion revascularization (TLR) rate

    Target lesion revascularization (TLR) rate, at 9 months

    Measured: 9 months

  6. Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate

    Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate, at 9 months

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2010 (estimated)
  2. Study startSep 2009
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01174433
Sponsor's protocol ID
2040P
Acronym
SAFE-TRY
Status last verified
Jul 2012
First submitted
28 Jul 2010
Last updated
4 Jul 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Tarantini G, La Vecchia L, Galli M, Favero L, D'Amico G, Buja P, Russo F, Cabianca E, Napodano M, Musumeci G, Franceschini E, Grassi G, Pavei A, Bonmassari R, Cernetti C, Spedicato L, Caprioglio F, Reimers B, Isabella G. Clinical outcome of patients with de novo coronary bifurcation lesions treated with the Tryton Side Branch Stent. The SAFE-TRY prospective multicenter single arm study. Int J Cardiol. 2013 Oct 15;168(6):5323-8. doi: 10.1016/j.ijcard.2013.08.008. Epub 2013 Aug 16.

    PubMed 24007969

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tryton in people with Coronary Artery Disease and Angioplasty, Transluminal, Percutaneous Coronary, run by University of Padova at 6 sites in Italy.

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 10 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: finished, as of the sponsor's last update on 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

A composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 30 days post procedure (time frame: 30 days (plus or minus 3 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01174433, which also lists 1 linked publication.

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 4 Jul 2012.

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