Stent Thrombosis Clinical Trial
— RegisterOfficial title:
Register of Patients Benefiting From a Coronary Bifurcation Angioplasty at the University Hospital of Nîmes and Montpellier in 2017
Verified date | July 2019 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Cardiovascular diseases are the second leading cause of death in France and the world's
leading cause.Coronary bifurcations are conducive to the development of atheromatous lesions
due to flow turbulence generating a pro-atherogenic effect. They represent about 15% of
coronary lesions and 30% of lesions in pluri truncular patients.Coronary bifurcation
angioplasty is a complex angioplasty with a high risk of complications.Numerous studies have
compared different angioplasty techniques with 2 stents in bifurcation lesions. However, two
studies of The Nordic-Baltic Bifurcation Study did not show at 6 months or 5 years of age any
significant difference in major cardiovascular events (death, heart attack, stent thrombosis,
emergency revascularization of the target vessel) in patients with a one-stent strategy
compared to the systematic use of two stents. There are also several post-expansion
techniques and the one that appears to be the most commonly used today (known as the
"KISSING-BALLOON") consists of inflating two balloons at the same time, one in the main
branch and the other in the daughter branch in order to open the meshes of the stent towards
the daughter branch. Studies on a test bench to evaluate the deformation of a stent in
different coronary anatomies according to the material and technique used have nevertheless
revealed several limitations to this technique, in particular an elliptical deformation of
the stent linked to the inflation of 2 simultaneous balloons.
From this work, a new technique known as "POT SIDE POT" was born, consisting in post dilating
the proximal part of the stent of the main branch in order to place it as closely as possible
against the wall, then open the stent meshes towards the lateral branch by balloon dilation
followed by a new post dilation of the proximal part of the mother branch stent to avoid the
use of 2 simultaneous balloons and thus reduce stent deformation by maintaining a circular
geometry while allowing proper stent attachment.
However, to date, there are no clinical studies comparing the POT SIDE POT technique with
that of KISSING-BALLOON in coronary bifurcation angioplasty.
This is why we would like to compare these two post-dilation techniques by a retrospective
study on the occurrence of major cardiovascular events and stent thrombosis in patients who
received a coronary bifurcation angioplasty in 2017 at the University Hospital of Nîmes.
Status | Completed |
Enrollment | 143 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All angioplasties of bifurcation lesion to a de novo stent defined by : - MEDINA classification 1,1,1,1 or 0,1,1,1 or 1,0,1 - Diameter of the mother and daughter branch > 2.5mm - No history of angioplasty of this bifurcation (de novo lesion) - Accessible for coronary angioplasty treatment - Patients admitted to the University Hospital of Nîmes from January 1 to December 31, 2017 Exclusion Criteria: - Minor patient - Bifurcation lesion not meeting the above criteria - Cardiorespiratory arrest - Injury on bypass surgery - Intrastent restenosis - 2-stent angioplasty technique |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nîmes | Nîmes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of a composite criterion associating major ischemic events (Major adverse Cardiac Events: death from any cause, myocardial infarction, need for revascularization) and the occurrence of stent thrombosis during hospitalization. | Occurrence of a composite criterion associating major ischemic events (Major adverse Cardiac Events: death from any cause, myocardial infarction, need for revascularization) and the occurrence of stent thrombosis during hospitalization. | within one year |
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