Study ID: ECLIPSE
Evaluation of treatment strategies for severe calcific coronary arteries: orbital atherectomy vs. conventional angioplasty technique prior to implantation of drug-eluting stents
This study, dubbed the ECLIPSE clinical trial, seeks to compare the safety and effectiveness of the Diamondback 360® Orbital Atherectomy System, which is a method for treating disease of the artery vs. traditional balloon angioplasty in patients before they are implanted with stents.
Participants will be grouped into one of two study arms: those who will receive the Orbital Atherectomy prior to stent implant and those who will be treated with conventional angioplasty prior to stent implant.
This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of a drug-eluting stent (DES).
There are two arms to this study:
- The Diamondback 360® Coronary Orbital Atherectomy System (OAS) will be used for orbital atherectomy vessel preparation prior to implantation of DES.
- Coronary balloons cleared or approved for commercial use by the FDA (cutting and scoring balloons are allowed) will be used for conventional balloon angioplasty prior to implantation of DES.
- Is participating in or will participate in any other investigational drug or device trial that has not reached its primary endpoint
- Pregnant women
- Has or will receive chemotherapy within 30 days prior or any time after the randomization procedure
- Has life expectancy of ≤ 12 months
- Underwent prior PCI in the target vessel or its branches 12 months before randomization
- Has major valve disease and underwent intervention within 30 days prior to randomization
- Has received a heart transplant
Other exclusion criteria apply. Please see the link below for more information.
Patients must have been diagnosed with stable ischemic heart disease or acute coronary syndrome and have a heavily calcified coronary artery(s) needing cardiac intervention.