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:
Information provided by (Responsible Party):
Hubertus von Korn, MD, Krankenhaus Hetzelstift
ClinicalTrials.gov Identifier:
NCT01538186
First received: February 17, 2012
Last updated: February 23, 2012
Last verified: February 2012
  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 Krankenhaus Hetzelstift:

Primary Outcome Measures:
  • Major adverse cardiac outcome [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538186

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

No publications provided

Responsible Party: Hubertus von Korn, MD, Head of the Department, Krankenhaus Hetzelstift
ClinicalTrials.gov Identifier: NCT01538186     History of Changes
Other Study ID Numbers: Hetzel01
Study First Received: February 17, 2012
Last Updated: February 23, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Krankenhaus Hetzelstift:
Coronary intervention
PCI of the side branch

ClinicalTrials.gov processed this record on July 22, 2014