May 28, 2013 > Local cardiologist begins stent trial
Local cardiologist begins stent trial
Submitted By Gisela Hernandez
On May 23, Dr. Ash Jain, a cardiologist who has been on the medical staff of Washington Hospital for 20 years, began a clinical trial of Absorb(tm), the world's first drug eluting bioresorbable vascular scaffold (BVS) for the treatment of coronary artery disease (CAD), narrowing of one or more arteries that supply blood to the heart. Like the more traditional metallic stents, this first-of-its-kind device restores blood flow to the heart. However, unlike its predecessors, the ABSORB stent naturally dissolves into the body and allows natural vessel function to return.
Dr. Jain will perform procedures in the Absorb Randomized Controlled Trial (RCT) Lead-In Phase for Abbott Vascular, which will involve up to 35 sites and 50 subjects. The outcomes from this trial will contribute to the evaluation of the potential advantages of a successful BVS, including:
* Eliminating stimulus for vessel inflammation and irritation
* Avoiding challenges and complications with leaving a metal implant behind
* Enabling vascular remodeling and tissue adaptation
* Restoring normal vasomotor function of the stented segment
"Heart disease is the number one killer of men and women, and the BVS could revolutionize treatment and advance the options for patient care," said Dr. Jain. "Clinical trials are one of the greatest ways to stay on top of best practices, and I am committed to pursuing treatments that could benefit patients in this community."
The outcomes from the lead-in phase will determine whether the physician training requires further modification to meet the needs of US physicians.
Following the lead-in phase, Washington Hospital will also participate in three RCT cohorts, known as Absorb III, Absorb Imaging, and Absorb IV. The pivotal trial will support the US pre-market approval of Absorb BVS System and evaluate the safety and effectiveness of the System compared to the commercially approved, control stent XIENCE. As in all clinical trials, the participating patients in the clinical trial will go through an extensive consent process.
"I am proud of Washington Hospital's role in advancing the field of medical discovery and improving outcomes for our patients," said Nancy Farber, CEO. "Dr. Jain is a true leader in his field and that leadership is improving our patient's outcomes."