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North Dallas Research Associates and Cardiac Center of Texas Begin Enrollment in TOBA II BTK Clinical Trial for New Peripheral Revascularization Treatment Option

Dr. Khan Deployed the First Below the Knee Tack System in the South East Region and Only Second in the Country      

 

MCKINNEY, Texas, March 2, 2017 /PRNewswire/ – North Dallas Research Associates and its private practice, Cardiac Center of Texas, announced today their participation in the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial. TOBA II BTK is a study that offers physicians a new option to treat patients suffering from advanced peripheral artery disease (PAD) or critical limb ischemia (CLI). Using the Tack Endovascular System®, the innovative technology is designed specifically to repair dissections following standard balloon angioplasty in the popliteal and tibial arteries with minimal stress to the vessels.

 

“We’re very excited to enroll the first patient in Texas to be treated in this groundbreaking clinical study,” said Dr. M. Akram Khan, Cardiologist at Cardiac Center of Texas. “TOBA II BTK provides the latest vascular technology for those in the Dallas area suffering from advanced PAD.”


PAD is a disease of the blood vessels in the legs and feet that occurs when arteries become narrow or clogged and don’t receive enough blood flow to meet the body’s needs. A recent analysis suggests more than 8 million Americans have peripheral artery disease, with 12-20% of individuals ages 65+ being affected. When left untreated, PAD can lead to critical limb ischemia (CLI), a more serious form of the disease. There are more than one million people in the United States living with CLI. CLI patients experience similar symptoms to PAD patients; however, CLI symptoms can significantly increase in severity from pain when resting, to open sores, to life-threatening conditions like gangrene, and can eventually require limb amputation in some patients. According to the U.S. Department of Health and Human Services, clogged arteries in the legs, just like clogged arteries in the heart, put individuals at risk for heart attack or stroke.

The Tack Endovascular System is equipped with self-sizing technology that allows one Tack implant to fit arteries ranging from 1.5mm to 4.5mm in diameter. This flexibility eliminates the need to precisely size the device to the arterial diameter, which is necessary with conventional stents. The device then allows physicians to “spot treat” the vessel only where dissections are present, rather than leave dissections untreated or covering them with large metal stents. This technique minimizes the amount of implanted metal and reduces vessel trauma and inflammation.

“Advanced PAD and CLI are large areas of fast-growing unmet need, both clinically and from a health economics perspective,” added Dr. Khan. “Patients with CLI suffer from debilitating symptoms and have few effective treatment options. It is important for the medical community to collaborate in this study to further the treatment options for patients with such advanced disease.”

Additional information regarding this trial can be found at clinicaltrials.gov by searching the term NCT02522884.

About the Tack Endovascular System and the TOBA II BTK Clinical Trial For more information about the TOBA II BTK trial, please visit www.intactvascular.com

About North Dallas Research Associates and Cardiac Center of Texas Established in 2003 by Dr. M. Akram Khan, NDRA has grown steadily for more than 10 years building expertise in clinical research operations. We are a team of professional and dedicated staff led by Dr. Khan, who manages and conducts a vast variety of clinical trials. Currently, the site has three principal investigators conducting clinical trials under various specialties.

For more information about North Dallas Research, visit www.ndresearch.com

At the Cardiac Center of Texas, we provide the residents of McKinney, Allen, Plano, Frisco, and the surrounding Collin County area with the most advanced cardiology treatment and prevention options. Beyond providing exceptional cardiology and vein care, we treat you with exceptional care. From our doctors, to our front desk and healthcare staff, at the Cardiac Center of Texas, we are dedicated to treating you with respect and compassion.

For more information about this facility, visit http://www.cardiaccenteroftexas.com

Tack Endovascular System® and Tack® are trademarks of Intact Vascular, Inc. CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.” The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC. Not available for sale or use in the United States.

Media Contacts Irfan Ullah, Director of Clinical Research North Dallas Research Associates 4201 Medical Center Drive, Suite 380 McKinney, TX 75069 irfan@ndresearch.com www.ndresearch.com

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