Sponsored by Cagent Vascular

The PRELUDE Study

 

The PRELUDE Study (PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Popliteal Artery Using the Serranator DevicE) is a single-arm, prospective, multicenter feasibility study enrolling up to 30 subjects with superficial femoral or popliteal lesions. The first case was performed in February 2017. The primary objectives are to collect safety and efficacy data, and to perform 30-day and 6-month follow-up. A secondary objective is to assess the feasibility of using OCT and/or IVUS in a subset of 10 patients to evaluate the presence of serrations. Dr. Andrew Holden (Auckland, New Zealand) is the Principal Investigator of the study, and the coinvestigators are Drs. Marianne Brodmann (Graz, Austria), Marek Krzanowski (Krakow, Poland), and Przemyslaw Nowakowski (Chrzanow, Poland).

CASE STUDY #1

Right Proximal Popliteal With Total Occlusion

Performed by Dr. Andrew Holden

The reference vessel diameter was 4.19 mm; lesion length was 54.28 mm; percent stenosis was 100% (A). A 5 mm X 80 mm Serranator® Alto was inflated to 6 atm (B). After treatment, residual stenosis was 20.23% (C).

CASE PRESENTATIONS

The cases presented here are five of the subjects enrolled in the PRELUDE study to date. The SFA and popliteal lesions (Case 1, Case 2, and Case 3) ranged from mild to severe calcification. Each case demonstrates effective lumen gain with minimal injury and no flow-limiting dissections after the use of Serranator® Alto.

The IVUS and OCT images (Case 4 and Case 5) demonstrate clear evidence of serration, disruption of intimal calcification, and acute lumen expansion.

Angiography core lab adjudication was performed at Yale Cardiovascular Research Group under the direction of Alexandra Lansky, MD, and OCT/IVUS core lab adjudication was completed by University Hospitals, Harrington Heart and Vascular Institute under the direction of Hiram Bezzera, MD.

These early clinical results indicate that the effect of Serranator® Alto on atherosclerotic and calcified lesions, previously seen in preclinical bench, animal, and cadaver studies, is confirmed.

Enrollment in the PRELUDE study is ongoing. Six-month follow-up on all subjects is expected to be completed in Q4 2017.

CASE STUDY #2

Right Distal SFA With Severe Calcification

Performed by Dr. Marek Krzanowski

The reference vessel diameter was 6.12 mm; lesion length was 30.04 mm; percent stenosis was 94.59% (A). A 6 mm X 40 mm Serranator® Alto was inflated to 11 atm (B). After treatment, residual stenosis was 24.07% (C).

CASE STUDY #3

Left Mid SFA

Performed by Dr. Przemyslaw Nowakowski

The reference vessel diameter was 5.15 mm; lesion length was 28.42 mm; percent stenosis was 77.02% (A). A 5 mm X 40 mm Serranator® Alto was inflated to 6 atm (B). After treatment, residual stenosis was 12.84% (C).

CASE STUDY #4

IVUS of Serration Effect in Mid-SFA Lesion

Performed by Dr. Przemyslaw Nowakowski

Controlled modification of severe intimal calcification by the Serranator® Alto. Note the controlled acute luminal gain of the impacted calcified intimal layer. —J. Mustapha, MD

Angiography by A. Lansky, MD, at Yale Cardiovascular Research Group. OCT/IVUS by H. Bezzera, MD, at University Hospitals, Harrington Heart and Vascular Institute.

CASE STUDY #5

OCT of Serration Effect

Performed by Dr. Andrew Holden

The OCT image shows clear evidence of serration caused by the Serranator® Alto device. —A. Holden, MBChB, FRANZCR, EBIR

Angiography by A. Lansky, MD, at Yale Cardiovascular Research Group. OCT/IVUS by H. Bezzera, MD, at University Hospitals, Harrington Heart and Vascular Institute.

 

Contact Info

For advertising rates and opportunities, contact:
Craig McChesney
484-581-1816
cmcchesney@bmctoday.com

Stephen Hoerst
484-581-1817
shoerst@bmctoday.com

Charles Philip
484-581-1873
cphillip@bmctoday.com

About Endovascular Today

Endovascular Today is a publication dedicated to bringing you comprehensive coverage of all the latest technology, techniques, and developments in the endovascular field. Our Editorial Advisory Board is composed of the top endovascular specialists, including interventional cardiologists, interventional radiologists, vascular surgeons, neurologists, and vascular medicine practitioners, and our publication is read by an audience of more than 22,000 members of the endovascular community.