In order to follow closely the new technologies which have been developed in the last few years to deal with the shortcomings of coronary angioplasty, a PTCA III Multidevice Registry is proposed under the leadership of Drs. Katherine M. Detre and Donald S.
B aim. This multicenter registry will be international in scope and will include eight centers currently participating in the 1985-86 Registry.
The specific aims of the proposed study are: 1.To prospectively evaluate new devices (including atherectomy devices, stents, and laser techniques) individually for acute in-hospital efficacy and safety in consecutive patients (up to 500 per device and 3,000 overall) . 2.To prospectively evaluate long-term efficacy and safety of new devices (with followup interviews at 6 weeks, 6 months, and 1 year, and repeat angiography at 6 months). 3.To identify the clinical and anatomic patient subsets that most benefit long-term from each device. 4.To compare acute and long-term results of each device to those of conventional PTCA in similar patient subsets (using comparability of definitions between Registries) . 5.To compare the acute and long-term safety and efficacy of several individual devices in clearly defined clinical and anatomic patient subsets. 6.To assess the learning curves associated with each new device. 7.To determine the optimal timing of widespread device usages and develop guidelines for the introduction of new devices into clinical trials. 8.To study the efficacy and safety of each device over time, taking into account changing baseline patient characteristics and indications. The existing Registry data collection mechanisms and organization will be modified to address these goals. We have collaborated with many of the 30 proposed centers in the PTCA Registries since 1980 and the BARI trial since 1987. These established arrangements and our experience in coordinating studies of coronary interventional procedures will assure timely, accurate collection and meaningful analysis of new device data.
| Saucedo, J F; Kennard, E D; Popma, J J et al. (2000) Importance of lesion length on new device angioplasty of native coronary arteries. NACI Investigators. New Approaches to Coronary Interventions. Catheter Cardiovasc Interv 50:19-25 |
| Saucedo, J F; Popma, J J; Kennard, E D et al. (2000) Relation of coronary artery size to one-year clinical events after new device angioplasty of native coronary arteries (a New Approach to Coronary Intervention [NACI] Registry Report). Am J Cardiol 85:166-71 |
| Baim, D S; Kent, K M; King 3rd, S B et al. (1994) Evaluating new devices. Acute (in-hospital) results from the New Approaches to Coronary Intervention Registry. Circulation 89:471-81 |
