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

Coronary Bifurcation Lesions Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538186
• Other study ID #: Hetzel01
• Status: Completed
• Phase: N/A
• First received: February 17, 2012
• Last updated: February 23, 2012
• Start date: January 2008
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Krankenhaus Hetzelstift
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Bifurcation Lesions

Locations

Country	Name	City	State
Germany	Hetzelstift	Neustadt/Weinstrasse	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Hetzelstift

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac outcome		12 months	No