Lehigh Valley Health Network Only in Region to Participate in Drug Coated Balloon Clinical Trial

Lehigh Valley Heart and Vascular Institute, part of Lehigh Valley Health Network (LVHN), announced its participation in the only clinical trial in our region testing drug coated balloons (DCB) as an alternative treatment for obstructed or clogged coronary arteries. Already approved in other countries, the drug coated balloons could signal a major turning point in the treatment of coronary disease and expand treatment options to patients currently not eligible.

Balloon angioplasty followed by stenting has been the standard in treating cardiac disease for over two decades. For eligible patients, the drug coated balloons could mean less stents and more opportunities for treatment of smaller arteries, and a chance to offer long-lasting improvements to blood flow.

“Now in the final phase, the clinical trial for this leading-edge treatment is big news in the world of interventional cardiology. It expands the possibilities for the types of blockages we’re able to treat,” says interventional cardiologist Chirdeep Patel, MD, with Lehigh Valley Heart and Vascular Institute. “For patients in need our hope is to bring them additional options and better outcomes.”

In balloon angioplasty, the cardiologist reaches the clogged artery by inserting a catheter into a large blood vessel and guiding it to the blockage. A balloon is then pushed through the catheter to reach the clogged area, where it is inflated to reopen the artery. The doctor then inserts a stent, a metal mesh tube-like structure that remains in the artery and keeps it open so blood can continue to flow freely again.

In the DCB procedure, balloons are coated with a drug that sticks to the wall of the artery and helps prevent the uncontrolled growth of cells that could re-block it. The balloon is inserted into the affected area and inflated there for approximately one minute. The medicine transfers to the artery and helps it stay open once the balloon is removed.

Unfortunately, over time, arteries with stents can become blocked again in a condition known as in-stent restenosis. Currently in the U.S., in-stent restenosis is the only condition drug coated balloons are approved to treat. That approval happened in July 2024. This trial additionally is designed to help treat patients who have blockages in native arteries that are too small to safely place a stent.

In the rest of the world, drug coated balloons have been approved for about a decade. Results from clinical trials and patient data looks very promising.

“The use of drug coated balloons to treat coronary disease has the potential to signal a real turning point in the field of interventional cardiology,” Dr. Patel says, “This leading-edge technology could allow us to treat many patients with better outcomes. It may signal a move away from putting stents in every artery.”

Dr. Patel says that with non-drug coated balloon angioplasty (“plain old balloon angioplasty") there is an approximately 50% chance of the blockage returning. The expectation is that with DCBs that percentage will be far lower.

The benefits for patients receiving DCB treatment versus traditional options include less layers of metal stents left behind inside the coronary arteries. In patients with in-stent restenosis, treatment often includes adding another stent or traditional balloon angioplasty. DCBs provide new hope of a lasting solution for these patients.  

DCBs may also allow for treatment of smaller arteries if the results of this trial are favorable. Stents are only available in certain diameters. Blocked arteries smaller than the available stents have previously been difficult to treat at all, or treat with enduring results.

“The possibilities for DCBs in the treatment of coronary disease are just beginning to be explored,” Dr. Patel says. “We hope this is the first of many approvals that could potentially change the course of how we treat patients in our field.”

Participating LVHN interventional cardiologists include:

• Eric Elgin, MD, Chief, Division of Cardiology, Heart and Vascular Institute
• Chirdeep Patel, MD
• Shailendra Singh, MD
• Nainesh Patel, MD

DCBs are for use in patients with coronary artery disease, particularly patients with in-stent restenosis or small vessel disease. Patients are evaluated by their physician and may be offered the option to participate in the trial if they qualify.

Dr. Patel says the goal for the trial will be to enroll three to five patients per month. The clinical trial is being managed by Medtronic, the manufacturer of the balloons. It will end once enough data has been captured from participating sites.

LVHN is a regional leader in clinical trials, offering research options for various medical conditions including rare cancers. Our decades of work in clinical trials helps you have a safe experience while receiving the very latest in revolutionary care. The Network Office of Research and Innovation (NORI) at LVHN manages all clinical research. For more information visit:

LVHN.org/research