NCT01174433

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for phase_1 coronary-artery-disease

Timeline
Completed

Started Sep 2009

Typical duration for phase_1 coronary-artery-disease

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

2.8 years

First QC Date

July 28, 2010

Last Update Submit

July 3, 2012

Conditions

Coronary Artery DiseaseAngioplasty, Transluminal, Percutaneous Coronary

Keywords

Bifurcation coronary artery diseasePercutaneous coronary interventionTryton Stent

Outcome Measures

Primary Outcomes (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.

    30 days (plus or minus 3 days)

Secondary Outcomes (6)

  • Angiographic and Procedural success

    30 days (plus or minus 3 days)

  • Total volume of contrast used

    24 hours

  • Total index PCI procedure time

    24 hours

  • Target vessel revascularization (TVR) rate

    9 months

  • Target lesion revascularization (TLR) rate

    9 months

  • +1 more secondary outcomes

Study Arms (1)

Tryton bifurcation stent system

EXPERIMENTAL
Device: Tryton

Interventions

TrytonDEVICE

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

Also known as: Tryton bifurcation stent system
Tryton bifurcation stent system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Castelfranco Veneto's Hospital

Castelfranco Veneto, 31033, Italy

Location

Conegliano's Hospital

Conegliano, 31015, Italy

Location

Angel's Hospital

Mestre, 30170, Italy

Location

Mirano's Hospital

Mirano, 30035, Italy

Location

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

Padua, 35128, Italy

Location

Vicenza's Hospital

Vicenza, 36100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 24007969DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Giuseppe Tarantini, MD, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 28, 2010

First Posted

August 3, 2010

Study Start

September 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

IT(6)