ILUMIEN IV: OPTIMAL PCI

  • STATUS
    Recruiting
  • End date
    Jul 31, 2022
  • participants needed
    3656
  • sponsor
    Abbott Medical Devices
Updated on 26 July 2020
Investigator
Mariah Tackett
Primary Contact
Kliniken der Friedrich-Alexander-Universit t (8.7 mi away) Contact
+80 other location
diabetes
angiography
coronary artery disease
chest pain
infarction
myocardial infarction
angina pectoris
stemi
unstable angina
infarct
troponin
ischemia
stable angina
exercise stress test
angina
optical coherence tomography
coronary disease
stent restenosis
clinical syndrome
acute myocardial infarction
stress test
chronic total occlusion
in stent restenosis

Summary

The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.

Description

This is a prospective, single-blind clinical investigation randomizing subjects to OCT-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio. The clinical investigation will be conducted at approximately 125 centers in North America (US and Canada), Europe, Middle East and Asia-Pacific.

All patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group will undergo a blinded post-PCI OCT run to allow comparison of OCT derived minimum stent area (MSA) in both groups.

After hospital discharge, all patients will have clinical follow-up at 30 days, 1 year, and 2 years.

Details
Treatment Coronary PCI guided by OCT, Coronary PCI guided by Angiography
Clinical Study IdentifierNCT03507777
SponsorAbbott Medical Devices
Last Modified on26 July 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet