Primary Objective: To demonstrate that IVUS with VH guidance leads to better post procedural outcome when compared to angiographic guidance only.Secondary Objective:To demonstrate that IVUS and VH guidance leads to lower occurrence of MACE at short…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Baseline demographics and anatomy will be displayed comparing the two treatment
groups: angiogram only and angiogram with VH-IVUS.
The three primary endpoints: correct identification of calcium presence,
accurate measurement of lesion length for stent sizing, and correct minimal
lumen CSA will be used to determine overall improved diagnostic accuracy.
Secondary outcome
Niet van toepassing
Background summary
Bifurcation lesions have a higher rate of restenosis and procedural
complications than non-bifurcation lesions and are associated with increased
risk for late stent thrombosis (LST). Fibroatheromas, repeated plaque ruptures,
and plaque progression are known to take place at low shear stress locations
and are thus a common finding at bifurcations. The location can vary from
proximal part of the bifurcation to the mid or even more distal location
depending on the stage of the disease, spatial orientation of the branching
arteries, and flow dynamics.
Different plaque types correlate with vessel remodeling. Lesion rich with
necrotic core, such as thin cap fibroatheromas, are associated with sudden
coronary death, can be positively remodeled and thus be angiographically
silent. Fibrofatty and fibrotic plaque compositions have been show to correlate
with plaque shift during balloon angioplasty. On the other hand, in lesions
rich with necrotic core, the necrotic core has been shown to be released into
the lumen during balloon angioplasty. A statistically significant, positive
correlation has been shown with the amount of necrotic core and the amount of
distal embolization (increase CK-MB and troponin I rise after stenting).
The first objective of this study is to demonstrate that pre-intervention
grayscale IVUS with VH can provide more accurate information on lesion
characteristics than information derived from pre-procedural angiogram only.
The second objectives of this study are to demonstrate that grayscale IVUS with
VH during and post intervention can guide to better procedural and long-term
outcome when compared to angiographic guidance only.
Study objective
Primary Objective:
To demonstrate that IVUS with VH guidance leads to better post procedural
outcome when compared to angiographic guidance only.
Secondary Objective:
To demonstrate that IVUS and VH guidance leads to lower occurrence of MACE at
short (30 days) and/or long term (2 years) when compared to angiographic
guidance alone. With regard to VH IVUS, special attention will be paid to the
impact of un- or partially covered confluent necrotic core against lumen
surface on long term clinical outcomes.
Tertiary Objective:
To demonstrate that grayscale with VH IVUS are more advanced diagnostic
techniques to provide pre- interventional knowledge of the amount, composition,
and location of the atherosclerotic plaque when compared to information
provided by pre-procedural angiogram.
Study design
Global, multi-center prospective, two-arm (blinded to IVUS grayscale and
VH-IVUS information vs. non-blinded), randomized study.
Intervention
The patient is scheduled for intervention of coronary bifurcation lesion using
DES stents
Study burden and risks
IVUS is a diagnostic technology, where a catheter is advanced into the coronary
artery. This additional step during the procedure will take some additional
treatment time (several minutes). The risks for using IVUS are identical as for
interventional procedures in general (such as bleeding at the entry puncture
site, injury to the vascular wall, thrombosis of
the vessel, and peripheral embolization).
Excelsiorlaan 41
1930 Zaventem
BE
Excelsiorlaan 41
1930 Zaventem
BE
Listed location countries
Age
Inclusion criteria
1. Patient must be greater than 18 years of age.
2. Patient is scheduled for coronary stenting of a bifurcation lesion in a native artery using Drug Eluting Stents.
3. Patient must be willing and able to read and sign the informed consent document before planned coronary intervention.
4. If the patient is female and of child bearing potential, a pregnancy test (serum HcG or urine dip stick) is negative within 7 days of the procedure.
5. Side branch lumen diameter min of >2 mm by visual, angiographic estimate.
6. Patient must agree to be available for follow-up at 30 days, 1 and 2 years after procedure.
7. Other significant lesions in different vessels should be treated successfully (residual stenosis < 30%, normal TIMI flow, no EKG modification) before treating the index bifurcation lesion.
Exclusion criteria
1. The patient experiences significant hepatic disease, renal disease, lung disease and/or malignant disease with unfavorable prognosis.
2. Any contraindications for IVUS interrogation as determined by the investigator including sever vessel tortuosity and severe calcification by angiogram.
The patient suffered a cerebrovascular accident within the past 6 months and has residual effects from the event.
3. The patient suffered significant (as determined by the Investigator) gastrointestinal bleeding within the past 3 months.
4. The most recent white blood cell count less than 3,000 cell/mm3 or the number of platelet is less than 100,000 cell/mm3.
5. The patient has contraindication to antithrombotic regimen or anticoagulation therapy.
6. The lesion is 0.0.1. (Medina classification).
7. The bifurcation lesion involves an anastamosis site from previous a coronary artery bypass surgery.
8. Acute MI or recent MI with CPK > 3 times the normal value prior to intervention (during index hospitalization).
9. Other significant lesion in the same vessel.
10. Other lesion in a different vessel not successfully treated.
Design
Recruitment
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 | NL24260.044.08 |