Proliferation Reduction with Vascular Energy Trial - PREVENT(Radiation)

Description:

Intracoronary radiation with P32 helical catheter for prevention of restenosis.

Hypothesis:

To evaluate the safety and efficacy of a P32 helical centering catheter and afterloader for the prevention of restenosis.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 84
Mean Follow Up: 6 months

Patient Populations:

Single de novo or restenotic lesion, with or without stent
Vessel size between 2.4 and 3.7mm
Lesion length < 22mm

Exclusions:

Previous radiation to heart
Myocardial infarction within previous 72 hours
Intracoronary thrombus

Primary Endpoints:

Major adverse cardiac events at 6 months
Binary restenosis at 6 months

Drug/Procedures Used:

Intracoronary radiation (2800, 3500, or 4200 cGy), or placebo

References:

1. Presented at AHA 71st Scientific Sessions, Dallas, TX

Keywords: Coronary Restenosis, Angioplasty, Balloon, Coronary, Stents


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