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

Primary Purpose

Coronary Artery Disease, Angioplasty, Transluminal, Percutaneous Coronary

Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Tryton
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Bifurcation coronary artery disease, Percutaneous coronary intervention, Tryton Stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

  • Castelfranco Veneto's Hospital
  • Conegliano's Hospital
  • Angel's Hospital
  • Mirano's Hospital
  • Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy
  • Vicenza's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tryton bifurcation stent system

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Total volume of contrast used
Total volume of contrast used, in mL
Total index PCI procedure time
Total index PCI procedure time, in minutes
Target vessel revascularization (TVR) rate
Target vessel revascularization (TVR) rate, at 9 months
Target lesion revascularization (TLR) rate
Target lesion revascularization (TLR) rate, at 9 months
Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate
Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate, at 9 months

Full Information

First Posted
July 28, 2010
Last Updated
July 3, 2012
Sponsor
University of Padova
Collaborators
Mirano's Hospital, Mirano, Italy, San Giacomo Apostolo Hospital, Castelfranco Veneto, Italy, Conegliano Veneto's Hospital, Conegliano Veneto, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01174433
Brief Title
Safety Study to Assess the FEasibility of Use of the TRYTON Bifurcation Coronary Stent System (SAFE-TRY)
Acronym
SAFE-TRY
Official Title
Safety Study to Assess the FEasibility of Use of the TRYTON Bifurcation Coronary Stent System (SAFE-TRY)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova
Collaborators
Mirano's Hospital, Mirano, Italy, San Giacomo Apostolo Hospital, Castelfranco Veneto, Italy, Conegliano Veneto's Hospital, Conegliano Veneto, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Angioplasty, Transluminal, Percutaneous Coronary
Keywords
Bifurcation coronary artery disease, Percutaneous coronary intervention, Tryton Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tryton bifurcation stent system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Tryton
Other Intervention Name(s)
Tryton bifurcation stent system
Intervention Description
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
Primary Outcome Measure Information:
Title
A composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 30 days post procedure
Description
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)
Secondary Outcome Measure Information:
Title
Angiographic and Procedural success
Description
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)
Time Frame
30 days (plus or minus 3 days)
Title
Total volume of contrast used
Description
Total volume of contrast used, in mL
Time Frame
24 hours
Title
Total index PCI procedure time
Description
Total index PCI procedure time, in minutes
Time Frame
24 hours
Title
Target vessel revascularization (TVR) rate
Description
Target vessel revascularization (TVR) rate, at 9 months
Time Frame
9 months
Title
Target lesion revascularization (TLR) rate
Description
Target lesion revascularization (TLR) rate, at 9 months
Time Frame
9 months
Title
Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate
Description
Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate, at 9 months
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Tarantini, MD, Ph.D.
Organizational Affiliation
University of Padua, Department of Cardiac, Thoracic and Vascular Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Castelfranco Veneto's Hospital
City
Castelfranco Veneto
ZIP/Postal Code
31033
Country
Italy
Facility Name
Conegliano's Hospital
City
Conegliano
ZIP/Postal Code
31015
Country
Italy
Facility Name
Angel's Hospital
City
Mestre
ZIP/Postal Code
30170
Country
Italy
Facility Name
Mirano's Hospital
City
Mirano
ZIP/Postal Code
30035
Country
Italy
Facility Name
Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy
City
Padua
ZIP/Postal Code
35128
Country
Italy
Facility Name
Vicenza's Hospital
City
Vicenza
ZIP/Postal Code
36100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24007969
Citation
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.
Results Reference
derived

Learn more about this trial

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

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