NCT01724957

Brief Summary

The study hypothesis: it is possible to use icECG recorded from regular PCI wire to predict significance of SB ostial stenosis after main vessel stenting in coronary bifurcation lesions.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

4.3 years

First QC Date

November 5, 2012

Last Update Submit

August 18, 2019

Conditions

Coronary Artery Disease

Keywords

Fractional flow reserve,coronary bifurcation stenosis,intracoronary ECG,coronary stentCoronary bifurcation lesionsicECG

Outcome Measures

Primary Outcomes (1)

  • Side branch region ischemia duration

    FFR\<0.80 at the SB ostium after stenting main vessel in coronary bifurcation lesion; icECG ST-segment elevation \>2.0mm; T-wave inversion \>3mm; ST-segment depression \>2mm, not observed at the beginning of procedure

    Percutaneous coronary intervention procedure time (up to 4h)

Secondary Outcomes (4)

  • Target lesion revascularization

    12 months

  • Number of patients not alive

    12 month

  • Myocardial infarction after hospital discharge

    12 months

  • New onset angina or heart failure symptoms

    12 months

Other Outcomes (1)

  • Periprocedural myonecrosis - extent of post PCI enzyme elevation

    48h

Study Arms (1)

Patients with coronary bifurcation lesions

Only one group will be studied. The patient will be a slef-reference.

Procedure: Intracoronary ECG

Interventions

Intracoronary ECGPROCEDURE

Recording of icECG from the tip of PCI guidewire. The wire end is connected through alligator clips to V-lead from surface ECG

Patients with coronary bifurcation lesions

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Significant, \>50% diameter stenosis artery scheduled for stent insertion at the main vessel (Medina types: 1xx, x1x, 11x); * Side branch vessel at least 2.0mm

You may qualify if:

  • Subject at least 18 years of age.
  • Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
  • 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) located in a native coronary artery with diameter of ≥ 2.0 mm.
  • Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.

You may not qualify if:

  • Subjects with significant ST-T change (≥ 1mm).
  • 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).
  • Subjects who refuse to give informed consent.
  • Subjects with the following angiographic characteristics: left main coronary artery stenosis, total occlusion before occurrence of SB, lesion of interest located at infarct-related artery.
  • Subjects with LVEF \< 30%.
  • Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy.
  • LBBB, RBBB, atrial fibrillation/flutter with no identifiable isoelectric line.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana-Purdue University

Indianapolis, Indiana, IN 46202, United States

ACTIVE NOT RECRUITING

National Heart Hospital

Sofia, 1309, Bulgaria

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Dobrin Vassilev, MD, PhD

CONTACT

00359886846550dobrinv@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dobrin Vassilev MD, PhD

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 12, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2020

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

US(1)BU(1)