To demonstrate the safety and effectiveness of the Tryton Side Branch Stent* with main branch approved DES compared to side branch balloon angioplasty and main branch approved DES in the treatment of de novo native coronary artery bifurcation…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint:
Target Vessel Failure (TVF) defined as the composite of cardiac death, target
vessel myocardial infarction (Q wave or non-Q wave) and target vessel
revascularization (main branch or side branch) of the Tryton Side Branch Stent*
with main branch DES compared to side branch balloon angioplasty and main
branch DES at 9 months.
Secondary outcome
Secondary Endpoints:
Powered Secondary Angiographic Endpoint (Angiographic Cohort):
In-segment % diameter stenosis of the Tryton Side Branch Stent* compared to
side branch balloon angioplasty at 9 months post-procedure.
Safety:
1. All-cause and cardiac mortality at 30 days, 6 and 9 months, and annually up
to 5 years;
2. Myocardial infarction (MI): Q-wave and non-Q-wave, cumulative and individual
at 30 days, 6 and 9 months, and annually up to 5 years;
3. Major Adverse Cardiac Event (MACE) defined as a composite of all cause
death, MI (Q wave or non-Q wave), emergent coronary artery bypass surgery
(CABG), or target lesion revascularization (TLR) by repeat PTCA or CABG at
hospital discharge, 30 days, 6 and 9 months, and annually up to 5 years;
4. The composite of cardiac death, myocardial infarction (Q wave or non-Q wave)
> 30 days post-procedure, stent thrombosis, and target vessel revascularization
(main branch or side branch);
5. Rates of stent thrombosis using ARC definition of definite and probable
stent thrombosis and categorized as early, late or very late, at 30 days, 6 and
9 months, and annually up to 5 years.
Effectiveness:
6. Device success, defined as attainment of <30% residual stenosis within the
side branch;
7. Lesion success defined as attainment of <50% residual stenosis using any
percutaneous method;
8. Procedure success defined as lesion success without the occurrence of
in-hospital MACE;
9. Clinically or ischemia-driven target lesion revascularization at 30 days, 6
and 9 months, and annually up to 5 years;
10. Clinically or ischemia-driven target vessel revascularization at 30 days, 6
and 9 months, and annually up to 5 years;
11. Clinically or ischemia-driven target vessel failure (defined as cardiac
death, target vessel MI (Q wave or non-Q wave) or target vessel
revascularization TVR) at 30 days, 6 and 9 months, and annually up to 5 years;
12. Clinically or ischemia-driven target lesion failure (defined as cardiac
death, target lesion MI (Q wave or non-Q wave) or target lesion
revascularization TLR) at 30 days, 6 and 9 months, and annually up to 5 years;
13. Target lesion failure (TLF) defined as cardiac death, target lesion MI (Q
wave or non-Q wave) and target lesion revascularization (TLR) at 30 days, 6 and
9 months, and annually up to 5 years.
Angiographic Cohort
14. In-stent and in-segment angiographic binary restenosis in the main branch
and bifurcation lesion at 9 months;
15. In-stent and in-segment lesion minimal lumen diameter (MLD) in the side
branch, main branch at 9 months;
16. In-stent, proximal and distal side branch, and main branch late lumen loss
at 9 months.
IVUS Cohort
17. Percent of subjects free of stent fracture;
18. Minimum lumen cross-sectional area (CSA) within 5mm from the carina in the
side branch;
19. Percent neointimal CSA at the site of the minimum lumen area;
20. Percent neointimal volume (equal to percent net volume obstruction or
neointimal volume/external elastic membrane volume) within 5mm distal to the
carina in the side branch;
21. Percent area stenosis (equal to minimum lumen area/reference area) in the
side branch;
22. Mean lumen CSA within 5mm distal to the carina in the side branch;
23. Stent apposition in the side branch and carina.
24. Stent apposition in the main branch
Background summary
This study is a post market, prospective multicenter, single blind and
randomized controlled study to do research on the safety and effectiveness of
the Tryton Side Branch Stent*. The Tryton Side Branch Stent* System is intended
for improving coronary lumen diameter of the side branch of de novo bifurcation
lesions in native coronary arteries in the side branch and in the main branch.
The Tryton Side Branch Stent* is intended for use in conjunction with
commercially available balloon expandable drug-eluting coronary stents (DES) in
the main branch. The study will be executed in up to 704 patient in up to 50
research centers in Europe, Israel and North-America. All patients will be
followed up on 30 days, 6 months, 9 months and yearly until 5 years
post-procedure.
Study objective
To demonstrate the safety and effectiveness of the Tryton Side Branch Stent*
with main branch approved DES compared to side branch balloon angioplasty and
main branch approved DES in the treatment of de novo native coronary artery
bifurcation lesions with side branch ranging in diameter from >=2.5 mm to <=3.5
mm and main branch ranging in diameter from >=2.5 mm to <=4.0 mm.
Study design
Prospective, multicenter, randomized, single blind controlled study.
Number of groups : 2
Group 1 :
treatment(s) : treatment with theTryton Side Branch StentTM plus approved main
branch DES
Group 2 (control cohort) :
treatment(s) : treatment with Side branch balloon angioplasty plus approved
main branch DES
Prospective, multicenter, randomized, single blind controlled study designed to
enroll up to 704 subjects who will be randomized in a 1:1 fashion to the Tryton
Side Branch Stent* with main branch approved DES (N=352) vs. side branch
balloon angioplasty (POBA) and main branch approved DES (N=352) for treatment
of native coronary artery bifurcation disease. The first 187 subjects enrolled
in each arm will return for angiographic follow-up at 9 months. The first 64
subjects randomized to the Tryton cohort and the first 32 subjects randomized
to the Control cohort will return for IVUS follow-up at 9 months at the same
time as the angiographic follow-up at designated IVUS sites.
Total number of pts in the study: 704
Expected start date : Feb 2011
Expected end date : Nov 2017
Intervention
Prospective, multicenter, randomized, single blind controlled study.
Number of groups : 2
Group 1 :
treatment(s) : treatment with theTryton Side Branch StentTM plus approved main
branch DES
Group 2 (control cohort) :
treatment(s) : treatment with Side branch balloon angioplasty plus approved
main branch DES
Prospective, multicenter, randomized, single blind controlled study designed to
enroll up to 704 subjects who will be randomized in a 1:1 fashion to the Tryton
Side Branch Stent* with main branch approved DES (N=352) vs. side branch
balloon angioplasty (POBA) and main branch approved DES (N=352) for treatment
of native coronary artery bifurcation disease. The first 187 subjects enrolled
in each arm will return for angiographic follow-up at 9 months. The first 64
subjects randomized to the Tryton cohort and the first 32 subjects randomized
to the Control cohort will return for IVUS follow-up at 9 months at the same
time as the angiographic follow-up at designated IVUS sites.
Study burden and risks
Known risks are associated with balloon inflation and stent implantation,
including death (0.2 - 0.5%), heart attack (4 - 5%), or emergency surgery
(0.5%). Other risks include (but are not limited to):
• Cardiac events such as inadequate or impaired blood flow to the heart causing
chest pain or discomfort (angina or angina symptoms), impaired pumping ability
of the heart, re-narrowing of a treated heart artery, collection of blood
around the lining of the heart, injury or tear in a heart artery, tear or
puncture in a heart wall, weakening and bulging in a heart artery, or an
unexpected need for immediate heart surgery.
• Irregularities in the heart rhythm such as very fast or slow beating of the
upper and/or the lower heart chambers, or disorganized beating of the lower
heart chambers.
• Stent events such as failure to place it in the desired spot in the heart
artery, clot or obstruction within the stent, unintended movement of the stent
in the heart artery, losing the stent in the circulation as it is placed,
inadequate expansion or fit of the stent in the heart artery.
• Respiratory events such as impaired ability of the lungs to provide oxygen
for body tissues, fluid build-up in the lungs, or breathing difficulties.
• Blood vessel events such as bleeding or blood collection at catheter entry
site/s in groin, high or low blood pressure, abnormal area or weakness in wall
of artery, abnormal connection between an artery and vein in the groin, injury
or tear in artery in groin leading to the heart, air, tissue debris, or blood
clot that moves to smaller vessels away from the heart and may block flow,
spasm in a vessel.
• Brain or nervous system events such as stroke, impaired brain function that
improves over time, nerve injury in brain or in other body parts.
• Bleeding events such as bruising, bleeding from the catheter groin site/s, or
bleeding in other body parts requiring a blood transfusion or other treatment.
• Kidney events such as impaired kidney function or kidney failure.
• Allergic or immune system events such as sensitivities or body reactions to
medications given such as contrast dye, heparin, aspirin, Plavix, drug/polymer
in the stent or other drugs the doctor prescribes for treating the heart
artery; or fever or infection.
1000 Park Forty Plaza Suite 325
Durham NC 27713
US
1000 Park Forty Plaza Suite 325
Durham NC 27713
US
Listed location countries
Age
Inclusion criteria
Patients must meet ALL of the following criteria:
General Inclusion Criteria
1. The patient must be >=18 and <= 90 years of age;
2. Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, IIB, IIC, IIIB, IIIC, and/or have objective evidence of myocardial ischemia);
3. Acceptable candidate for CABG;
4. The intent to treat the side branch of the target bifurcation based on angiographic evaluation;
5. The patient is willing to comply with specified follow-up evaluations;
6. 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 Medical Ethics Committee (MEC) or Institutional Review Board (IRB).
7. Planned use of one of the following approved and commercially available drug-eluting stents for subject*s index procedure: CYPHER®, RESOLUTE Family of products (ENDEAVOR®
RESOLUTE or RESOLUTE INTEGRITY), PROMUS®, PROMUS ELEMENT Family of products (PROMUS® ELEMENT or PROMUS ELEMENT PLUS), XIENCE* V, or the XIENCE
PRIME Family of products (XIENCE PRIME, XIENCE Xpedition or XIENCE PRO)
Angiographic Inclusion Criteria
8. a)Single de novo lesion in a bifurcation involving both the main branch and the side branch with
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);
9. Target lesion located in a native coronary artery;
10. a)Bifurcation lesion main branch reference vessel diameter must be >=2.5 mm to <= 4.0 mm
b) Side branch reference vessel diameter must be >=2.5 mm to <= 3.5 mm by visual estimate;
11. a) Bifurcation lesion main branch lesion length <= 28 mm
b) Side branch lesion length <= 5.0 mm (the ability to be treated with a single stent for both main and side branch);
12. Target lesion >=50% and <100% stenosed by visual estimate in both the main branch and side branch;
Refer to Protocol 1.9.5 for full list of Inclusion Criteria
Exclusion criteria
Patients will be excluded if ANY of the following conditions apply:
General Exclusion Criteria
1. 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;
2. Patient has had a known diagnosis of STEMI acute myocardial infarction (AMI) within 72 hours preceding the index procedure or >72 hours preceding the index procedure and CK and CK-MB have not returned to within normal limits at the time of procedure;
3. Patients with non-STEMI within 7 days prior to index procedure with continued CK-MB elevation;
4. Patients with non-target lesion PCI within 7 days prior to index procedure with continued CK-MB elevation;
Angiographic Exclusion Criteria
5. Left main coronary artery disease (protected and unprotected)
6. Trifurcation lesion;
7. Totally occluded target vessel (TIMI flow 0 or 1);
8. Severely calcified target lesion(s);
9. Highly calcified target lesion(s) requiring rotational atherectomy;
10. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
11. Angiographic evidence of thrombus in the target lesion(s);
Refer to Protocol for full list of Exclusion Criteria.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34621.078.10 |