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ECLIPSE Study for Cardiac Stent Placement - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn the best way to prepare calcified arteries around your heart before placing a stent.

What is the Condition Being Studied?

Heart disease (patients with blocked arteries scheduled for stent placement).

Who Can Participate in the Study?

Adults who are
- Diagnosed with heart disease with severe calcification of the arteries
- Need treatment of your calcified arteries in the cardiac cath lab
- Have not received a heart transplant
- Are not allergic to egg yolks, soybean oil, glycerin, or sodium hydroxide

For more information about who can participate in this study, please contact the study team.

Age Group
Adults

What is Involved?

If you choose to join the study you will:

- Answer a questionnaire about your heart symptoms
- Have three blood tests and two EKG readings done while you are in the hospital
- Have images of your coronary arteries (the blood vessels around your heart) taken using fluoroscopy (a type of x-ray)

- Be randomly assigned (like the flip of a coin) to one of two treatment strategies to prepare your blocked artery for a stent, both of which are currently FDA approved and used at Duke to treat severe coronary artery disease (CAD)
-- Orbital atherectomy (OA)
OR
-- Standard angioplasty
- Treatment of the blockage using the strategy you're assigned to

- Have 4 follow-up phone calls at 30 days, 90 days, 1 year, and 2 years to see how you've been feeling, and if you have had any further heart issues

- This study will also collect information from your hospital bills related to this procedure

Study Details

Full Title
Evaluation of Treatment Strategies for Severe Calcific Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug Eluting Stents
Principal Investigator
Interventional Cardiologist
Protocol Number
IRB:PRO00085962
NCT:NCT03108456
Phase
Phase IV
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698