Status:
COMPLETED
Safety Study to Assess the FEasibility of Use of the TRYTON Bifurcation Coronary Stent System (SAFE-TRY)
Lead Sponsor:
University of Padova
Collaborating Sponsors:
Mirano's Hospital, Mirano, Italy
San Giacomo Apostolo Hospital, Castelfranco Veneto, Italy
Conditions:
Coronary Artery Disease
Angioplasty, Transluminal, Percutaneous Coronary
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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.
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT01174433
Start Date
September 1 2009
End Date
June 1 2012
Last Update
July 4 2012
Active Locations (6)
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1
Castelfranco Veneto's Hospital
Castelfranco Veneto, Italy, 31033
2
Conegliano's Hospital
Conegliano, Italy, 31015
3
Angel's Hospital
Mestre, Italy, 30170
4
Mirano's Hospital
Mirano, Italy, 30035