Outcomes 2019 - Baylor Scott & White Heart and Vascular Hospital BSWHHVH_646_2019 Outcomes JOOMAG MOD | Page 28

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Shockwave Coronary Intravascular
Lithotripsy System ® – peripheral use and
coronary clinical trial
In fiscal year 2019, interventional cardiologists
and vascular surgeons on the medical staff of
Baylor Scott & White Heart and Vascular Hospital
– Dallas were some of the first specialists in
North Texas to use the Shockwave Intravascular
Lithotripsy System ® (IVL) to treat peripheral
artery disease.
The peripheral IVL System that is already
approved for use is effective in addressing the
most difficult to treat patients with intimal and
deep wall medial calcium. The IVL System has
sizes capable of treating above and below the
knee and is also being used in patients with
heavily calcified iliac arteries in order to facilitate
the transfemoral delivery of sophisticated
devices in TAVR, EVAR and TEVAR and high-
risk PCIs that require an Impella ® device. The
new technology enables this patient group to
benefit from this innovative technology when
they would otherwise be ineligible for the
procedure or would be at an increased risk for
procedural complications.
Coronary use clinical trial
Baylor Scott & White Heart and Vascular
Hospital – Dallas began enrolling patients
in a worldwide clinical trial to evaluate the
safety and effectiveness of the Shockwave
coronary intravascular lithotripsy system. The
investigational technology uses a balloon
catheter system designed to enhance stent
outcomes by enabling delivery of the calcium
disrupting capability of lithotripsy prior to
balloon dilatation at low pressures. The
single-use sterile catheter contains multiple
lithotripsy emitters enclosed in an integrated
balloon. The emitters create sonic pressure
waves in the shape of a sphere, creating a field
effect to disrupt and fracture calcium in the
affected artery. For more information about
the Disrupt CAD III Study with the Shockwave
Coronary Intravascular Lithotripsy System ® , visit
BaylorHeartHospital.com/ClinicalTrials. Primary
Investigator: Robert M. Stoler, MD, FACC, FSCAI
Clinical trials
Throughout the years, clinical trials have been a
mainstay in the interventional cardiology arena
at Baylor Scott & White Heart and Vascular
Hospital – Dallas.
Trials in fiscal year 2019 included:
• Treatment of coronary artery disease with the
newest generations of drug-eluting stents
• New dosing strategies for medications used
to prevent clots in stents
• Gene therapy for coronary disease not
treatable with balloons and stents
• Treatment of stenosis in the renal (kidney)
arteries in patients with refractory high
blood pressure
• New devices and stents to treat peripheral
arterial disease
• Stents for the carotid arteries
• Closure for atrial septal defects and patent
foramen ovale
For more information and a complete
list of updated clinical trials, visit
BaylorHeartHospital.com/ClinicalTrials.