Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04011046
Other study ID # Local/2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2017

Study information

Verified date July 2019
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Stent


Locations

Country Name City State
France CHU de Nîmes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT01205776 - EXCEL Clinical Trial N/A
Completed NCT01231035 - REsponsiveness to CLOpidogrel and Stent-related Events in Acute Coronary Syndromes (RECLOSE 2 - ACS) N/A
Completed NCT01182428 - XIENCE V: SPIRIT WOMEN Sub-study Phase 4
Completed NCT04580602 - Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects
Completed NCT01205789 - EXCEL Clinical Trial (Universal Registry) N/A
Completed NCT00647504 - Prospective Clinical Observational Registry Including Consecutive Patients With In-stent Restenosis or Stent Thrombosis N/A
Active, not recruiting NCT00905008 - Long-Term Safety of Drug Eluting Stents in the "Real World" (FReIburger STent Registry) N/A
Completed NCT03118895 - Leaders Free III: BioFreedom™ Clinical Trial N/A
Completed NCT01249027 - XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
Recruiting NCT06075602 - COMPLEX Registry - A Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting With compLEX and Calcified Coronary Artery Disease
Completed NCT03209843 - Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO) N/A
Completed NCT01086228 - XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan N/A
Recruiting NCT05244629 - Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia N/A
Completed NCT00998127 - Patterns of Non-Adherence to Dual Anti-Platelet Regimen In Stented Patients N/A
Completed NCT00180479 - SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) Phase 3
Recruiting NCT04988685 - SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters
Completed NCT03544294 - veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study
Completed NCT04734028 - PTRG-DES Consortium
Completed NCT01894152 - XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
Completed NCT00496938 - XIENCE V: SPIRIT WOMEN Phase 4