Comparison Between Main Branch and Side Branch Vessels | NCT01046409

Studies
Comparison Between Main Branch and Side Branch Vessels

NCT01046409

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Aug 22, 2011Estimated

Enrollment

51Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Measuring collateral flow

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Jan 8, 2010

First Submission Date that Met QC Criteria

Jan 10, 2010

First Posted Date

Jan 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2011

Last Update Posted Date

Aug 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this trial is

to compare the clinical significance of the main vessel and the side branch vessel using EKG, pain score and coronary wedge pressure
to develop a new scoring system to predict the clinical significance of a side branch

Detailed Description

Clinical significance EKG change, pain score during 1 min balloon occlusion
Different characteristics between ST segment elevation vs non-elevation side branches
Comparison of coronary wedge pressure
Establishing a new scoring system to predict the ST elevation during 1min balloon occlusion

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

51Estimated

Label	Type	Description	Intervention Names
Main vessel, side branch vessel			Other: Measuring collateral flow

Name	Type	Description	Arm Group Labels	Other Names
Measuring collateral flow	Other	Measuring collateral flow using pressure and/or velocity coronary wire	Main vessel, side branch vessel

Measure	Description	Time Frame
ST elevation during 1min balloon occlusion		Day 1 after PCI

Measure	Description	Time Frame
Pain score during 1min balloon occlusion		Day 1 after PCI
coronary wedge pressure		during the procedure
Usefulness of new scoring system

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18
Able to verbally confirm understandings of risks, benefits of receiving percutaneous coronary intervention (PCI) for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
Significant stenosis at bifurcation lesion (>50% by visual estimate) which always includes stenosis of side branch (true bifurcation)
Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) in a native coronary artery with diameter of ≥ 2.25 mm
Target lesion(s) amenable for PCI with final kissing balloon angioplasty for the side branch

Exclusion Criteria:

Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
Patients refuse to give informed consent
Patients with left main coronary artery stenosis
Patients with total occlusion of the bifurcation lesion
Patients with infarct-related artery at the lesion of interest
Patients with left ventricular ejection fraction<40%
Patients with primary cardiomyopathy
Patients with chronic kidney disease defined as serum Cr>2.0
Patients who have severe side effects or contraindication to adenosine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with significant coronary artery disease, involving the bifurcation lesions

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16098427	Background	Koo BK, Kang HJ, Youn TJ, Chae IH, Choi DJ, Kim HS, Sohn DW, Oh BH, Lee MM, Park YB, Choi YS, Tahk SJ. Physiologic assessment of jailed side branch lesions using fractional flow reserve. J Am Coll Cardiol. 2005 Aug 16;46(4):633-7. doi: 10.1016/j.jacc.2005.04.054.
8462157	Background	Pijls NH, van Son JA, Kirkeeide RL, De Bruyne B, Gould KL. Experimental basis of determining maximum coronary, myocardial, and collateral blood flow by pressure measurements for assessing functional stenosis severity before and after percutaneous transluminal coronary angioplasty. Circulation. 1993 Apr;87(4):1354-67. doi: 10.1161/01.cir.87.4.1354.

ID	Term
D003324	Coronary Artery Disease
D009203	Myocardial Infarction
D017202	Myocardial Ischemia

ID	Term
D003327	Coronary Disease
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis