← Back to Search

Stent Implantation

Coronary PCI guided by Angiography for Coronary Artery Disease

N/A
Waitlist Available
Led By Ziad A Ali, MD, DPhil
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
i. Medication-treated diabetes mellitus, AND/OR B) High angiographic-risk lesion(s), with at least one target lesion in each target vessel planned for randomization meeting at least one of the following criteria;
A) High clinical-risk, defined as;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights

Study Summary

This trial is testing whether using a OCT-guided stent results in better outcomes than using an angiography-guided stent for people with high-risk characteristics or angiographic lesions.

Eligible Conditions
  • Coronary Artery Disease
  • Atherosclerosis
  • Coronary Artery Stenosis
  • Heart Attack
  • Myocardial Infarction

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have diabetes that requires medication, or you have a high-risk blockage in your blood vessels that meets certain criteria.
Select...
I'm sorry, it seems that the criterion is incomplete. Can you please provide me with additional information?
Select...
If your tumor has a long target area, it may be treated with a single long stent or multiple overlapping stents.
Select...
If you have a maximum of two abnormal areas in one blood vessel, and your doctor has used non-overlapping stents to treat them, these areas can be in the same part of the vessel or in different parts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical outcome (Powered): Rate of Target vessel failure (TVF)
Imaging Outcome (Powered): Mean change in Minimal stent area (MSA), continuous measure
Secondary outcome measures
Rate of Target vessel failure (TVF) excluding periprocedural MI (Powered)
Other outcome measures
Additional Procedural endpoint (Non Powered): Number of Participants With Other interventions
Additional Procedural endpoint (Non Powered): Number of Participants With Performance of atherectomy
Additional Procedural endpoint (Non Powered): Number of Participants With Thrombus aspiration
+55 more

Trial Design

2Treatment groups
Active Control
Group I: Coronary PCI guided by AngiographyActive Control1 Intervention
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.
Group II: Coronary PCI guided by OCTActive Control1 Intervention
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed.

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
635 Previous Clinical Trials
402,545 Total Patients Enrolled
102 Trials studying Coronary Artery Disease
123,615 Patients Enrolled for Coronary Artery Disease
AbbottIndustry Sponsor
748 Previous Clinical Trials
474,794 Total Patients Enrolled
42 Trials studying Coronary Artery Disease
159,364 Patients Enrolled for Coronary Artery Disease
Ziad A Ali, MD, DPhilPrincipal InvestigatorSt Francis Hospital and Heart Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any institutes in North America administering this research?

"Patients are being recruited for this trial from Providence Everett Medical Center in Washington, Hamilton Health Science Centre in Ontario, QE II Health Sciences in Nova Scotia and 47 other locations."

Answered by AI

Is this medical experiment currently open to recruitment?

"Clinicaltrials.gov confirms that this medical trial is not presently enlisting study members, with the initial posting dating back to March 26th 2018 and last update on April 25th 2022. Nevertheless, there are currently 973 other clinical studies actively looking for participants."

Answered by AI

What aims is this research endeavor hoping to accomplish?

"The primary purpose of this clinical trial is to evaluate target vessel failure over 24 hours, on average. Secondary objectives include collecting data regarding the total number of post-dilatation balloons used per subject, time from first wire insertion to guide catheter removal, fluoroscopy time, radiation exposure and thrombus aspiration as it relates to OCT imaging in the pre-PCI or post-stent run."

Answered by AI
~394 spots leftby Mar 2025