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

NCT01538186 | Completed

• 1 other identifier: Hetzel01
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Bifurcation Lesions

Keywords

Coronary intervention; PCI of the side branch

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac outcome

  12 months

Study Arms (2)

PCI without treating the side branch

PCI with treating the side branch

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Krankenhaus Hetzelstift: lead

Study Sites (1)

Hetzelstift

Neustadt/Weinstrasse, Rhineland-Palatinate, 67434, Germany

Location

Related Publications (1)

• von Korn H, Stefan V, van Ewijk R, Chakraborty K, Sanwald B, Andel R, Hemker J, Hink U, Ohlow M, Lauer B, Muenzel T. Treatment of coronary bifurcation lesions: stent-covering of the side branch with and without PCI of the side branch: a retrospective analysis of all consecutive patients. BMC Cardiovasc Disord. 2013 Apr 4;13:27. doi: 10.1186/1471-2261-13-27.

  PMID: 23557395 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: February 24, 2012
• Study Start: January 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: February 1, 2012
• Last Updated: February 24, 2012

Record last verified: 2012-02

Locations

DE (1)