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Treatment Of Coronary Bifurcation Lesions: Stentcovering Of The Side Branch With And Without PCI Of The Side Branch: A Retrospective Analysis Of All Consecutive Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01538186
First Posted: February 24, 2012
Last Update Posted: February 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hubertus von Korn, MD, Krankenhaus Hetzelstift
  Purpose

This retrospective observational study included patients (pts) with percutaneous coronary intervention (PCI) of a de novo coronary bifurcation lesion in one German center between January 2008 - August 2011. The investigators included all consecutive patients where the side branch was covered with a stent. Patients with ACS/cardiogenic shock were not excluded.

Two different methods were compared: group A represents patients with a simple strategy without any treatment of the side branch (SB). Group B consisted of patients where the SB was treated (PCI and/or stenting).

For the treatment of bifurcation lesions we used the concept of "provisional stenting", indications for the treatment of the SB were residual stenosis > 50 %, TIMI flow reduction < 2. Final-kissing PCI was intended in all patients of group B.

MACE during follow-up was evaluated in all patients.


Condition
Coronary Bifurcation Lesions

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Of Coronary Bifurcation Lesions: Stentcovering Of The Side Branch With And Without PCI Of The Side Branch: A Retrospective Analysis Of All Consecutive Patients

Further study details as provided by Hubertus von Korn, MD, Krankenhaus Hetzelstift:

Primary Outcome Measures:
  • Major adverse cardiac outcome [ Time Frame: 12 months ]

Enrollment: 98
Study Start Date: January 2008
Study Completion Date: February 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
PCI without treating the side branch
PCI with treating the side branch

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This retrospective observational study included patients (pts) with PCI of a de novo coronary bifurcation lesion in one German center between January 2008 - August 2011. We included all consecutive patients where the side branch was covered with a stent. Patients with ACS/cardiogenic shock were not excluded.
Criteria

Inclusion Criteria:

  • All consecutive patients with a bifurcation lesion, where the side branch was covered with a stent placed inside the main branch.

Exclusion Criteria:

  • Patients with an in-stent-restenosis, patients with a therapy using a drug coated balloon during the procedure (inside the main branch and/or the side branch) and patients where the side branch was not covered by the stent inside the main branch.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538186


Locations
Germany
Hetzelstift
Neustadt/Weinstrasse, Rheinland-Pfalz, Germany, 67434
Sponsors and Collaborators
Krankenhaus Hetzelstift
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hubertus von Korn, MD, Head of the Department, Krankenhaus Hetzelstift
ClinicalTrials.gov Identifier: NCT01538186     History of Changes
Other Study ID Numbers: Hetzel01
First Submitted: February 17, 2012
First Posted: February 24, 2012
Last Update Posted: February 24, 2012
Last Verified: February 2012

Keywords provided by Hubertus von Korn, MD, Krankenhaus Hetzelstift:
Coronary intervention
PCI of the side branch