November 12 1998  


 

Veenendaal, The Netherlands, 12 November 1998 - Nucletron B.V. today announced encouraging first results of the PARIS feasibility study. In this multicenter study patients undergoing balloon angioplasty to open narrowed leg arteries also received endovascular radiation using the Nucletron® Paris® Centering Catheter System in combination with Nucletron's main product, the microSelectron-HDR™ remote afterloader.


The first group of 36 patients has completed the 6-month follow-up and shows very good clinical results expressed as improvement of the blood flow in the treated leg and the overall walking ability.


Angiographic results available from 26 patients confirm the clinical findings: restenosis of the treated segment was seen in only 3 patients (11.5%) and in 2 of these (7.7%) it was located at the site of the original lesion. The historic restenosis rate after angioplasty in these patients ranges from 40 to 60%.


Ron Waksman, M.D., from the Washington Cardiology Research Foundation presented these results at the 71st Scientific Sessions of the American Heart Association in his role as Principal Investigator of the PARIS study.


PARIS is a multicenter study to evaluate the efficacy of endovascular radiation in reducing the problem of restenosis in the femoral-popliteal arteries. It is the first FDA-approved study of peripheral endovascular radiation therapy.


The feasibility phase of the study involved 40 patients and began in 1997 at five sites in the USA. In May 1998, the FDA gave the green light to continue the study into the double-blind, randomized phase. This will involve 300 patients who will be randomized to receive either actual radiotherapy or a dummy treatment at more than 15 hospitals in the USA and Europe.


Endovascular brachytherapy is performed immediately after angioplasty by advancing a wire, with a sealed miniature radioactive source at its end, through a Nucletron Paris centering catheter to the site of the angioplasty. A typical radiation procedure takes 5 to 10 minutes.


The Nucletron Paris catheter has multiple low-pressure balloons designed to promote centering of the radioactive source within the artery. Centering is important for an optimal dose distribution into the vessel wall. The Nucletron Paris catheter is manufactured by the Vascular Intervention division of Guidant Corporation in the USA.


Source storage and remote control manoeuvring is performed by the Nucletron microSelectron-HDR™ afterloader. With over 800 systems currently in use worldwide for cancer treatment, the microSelectron-HDR™, which is known for its safety and reliability, is the dominant afterloader product in the radiotherapy market.