Sternal Cerclage (sternal bone closure after open heart surgery)

  • STATUS
    Recruiting
  • sponsor
    Heart Lung and Blood Institute
Updated on 5 February 2021
acute coronary syndrome
coronary revascularization
revascularisation

Summary

The purpose of the study is to learn which treatment option is better for patients who have multi-vessel coronary artery disease (blockages in more than one vessel supplying blood to the heart muscle).


Description

The treatment options this study will compare are: (1) Hybrid Coronary Revascularization [HCR] (a combination of surgery and catheter procedures to open up clogged heart arteries) and (2) Percutaneous Coronary Intervention [PCI] (catheter procedures alone to open up clogged heart arteries). There are no new or "experimental" procedures being tested in this study: both HCR and PCI are well-established procedures and are regularly performed in patients who have coronary artery disease. But, the FDA has not approved the drug-eluting stents used in PCI for all types of coronary artery disease. We have received an Investigational Device Exemption from the FDA to use the drug-eluting stents in this trial in the same way that they are used in clinical practice. The study being proposed here will use rigorous scientific methods and should result in a very high level of certainty about which procedure is best for patients with coronary artery disease. Patients randomized to Hybrid therapy will undergo robotic midcab + drug eluting stent/stents at our facilities.

 

Details
Condition Coronary Artery Disease
Clinical Study IdentifierTX133848
SponsorHeart Lung and Blood Institute
Last Modified on5 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

•Signed informed consent, inclusive of release of medical information, and
Health Insurance Portability and Accountability Act (HIPAA) documentation (US
sites)
•Age ≥ 18 years
•Clinical indication for coronary revascularization that will be determined by
both a surgeon and an interventional cardiologist together
(Coronary anatomy requiring revascularization will be discussed with you
during your visit with cardiology to determine eligibility.)
◦Multivessel Coronary Artery Disease (CAD) involving the Left Anterior
Descending (LAD) (proximal or mid) and/or Left Main (ostial, mid-shaft or
distal) with at least 1 other epicardial coronary artery requiring treatment
(LCX or RCA), OR
◦Single vessel disease involving the LAD and a major diagonal, with both
requiring independent revascularization with at least one stent if randomized
to HCR and stents for both the LAD and diagonal if randomized to multivessel
PCI
Note: Other inclusions apply as determined by clinical evaluation and
angiogram imaging
•Ability to tolerate and no plans to interrupt dual anti-platelet therapy for
≥ 6 months if presentation with stable CAD, or ≥ 12 months if presentation
with biomarker positive acute coronary syndrome (ACS)
•Willing to comply with all protocol required follow-up

Exclusion Criteria

•Previous cardiac surgery of any kind, including CABG
•Previous thoracic surgery involving the left pleural space
•Previous LM or LAD stent (a) with evidence of in-stent restenosis or (b)
within 1 cm of a qualifying lesion
•Previous PCI of the LM and/or LAD within 12 months prior to randomization
•PCI with bare metal stent (BMS) within 12 months prior to randomization
•Any complication or unsuccessful revascularization with PCI within 30 days
prior to randomization
Other Details
Participating in a study is a personal decision. Discuss with your family
members and doctor before deciding to join a study. You or your doctor may
contact the study research staff to learn more about this study
NCT0308939
Clear my responses

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

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

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

Learn more

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

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

user name

Added 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 annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note