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Mechanism and Predictor of Side Branch Jailing (PRESSURE)

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00553670
First received: November 1, 2007
Last updated: March 28, 2011
Last verified: March 2011
  Purpose

Coronary artery bifurcation lesion is still one of the most challenging lesion subsets in the field of non-surgical treatment for a stenotic coronary artery. When one stent is placed in the main brach, it increases the side branch's stenosis degree. However, its mechanism and incidence are not known. This study will be performed to search for the mechanism and incidence of that phenomenon.


Condition
Bifurcating Coronary Artery Lesions
Main Branch Stent Implantation
Side Branch Jailing

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Predictor and Mechanism of a Side Branch Jail After Main Branch Stent Implantation in Bifurcation Lesions

Further study details as provided by Seoul National University Hospital:

Estimated Enrollment: 100
Study Start Date: November 2007
Study Completion Date: May 2009
Groups/Cohorts
1
Patients with elective coronary intervention for LAD-diagonal bifurcation lesion with provisional side branch intervention strategy with successful intravascular ultrasound and fractional flow reserve measurement

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with bifurcating coronary artery lesion in left anterior descending coronary artery

Criteria

Inclusion Criteria:

  1. Elective coronary intervention (including stabilized ACS patients)
  2. Bifurcation lesion with TIMI 3 flow
  3. Side branch diameter > 2mm, side branch lesion length < 10mm by visual estimation

Exclusion Criteria:

  1. Left main coronary disease
  2. AMI, or Old MI at LAD territory
  3. LVEF < 40%, or other significant valvular or myocardial disease
  4. Significant side branch distal lesion
  5. Angiographically visible thrombus
  6. Heavily calcified lesion
  7. Side branch predilatation before main branch stent implantation
  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: NCT00553670

Locations
Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of, 110744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Bon-Kwon Koo, PhD Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00553670     History of Changes
Other Study ID Numbers: H-0707-022-212
Study First Received: November 1, 2007
Last Updated: March 28, 2011
Health Authority: Korea: Food and Drug admministration

Keywords provided by Seoul National University Hospital:
coronary artery
bifurcation
stent
intravascular ultrasound
fractional flow reserve

ClinicalTrials.gov processed this record on November 20, 2014