Table IV.
Credentialing process for interventionists in major recent trials of carotid stenting
| Trial | Interventional committee | Total stent cases | Carotid stent cases | Interventionists reviewed | Interventionists approved | Cases reviewed |
|---|---|---|---|---|---|---|
| EVA-3Sa | Not stated | 35 any endovascular cases (or 12 CAS) | 12 | Not stated | Not stated | Not stated |
| SPACE | No | 25 | Not stated | Not stated | Not stated | |
| ICSSb | Not stated | 50 | 10 | |||
| CREST | Yes | Not stated | $35 cases with additional 5 to 20 in lead-in studyc | 427 | 238 (56%) | 10,164 |
| ACST-2 | Yes | Not stated | 25 within prior 2 years | Trial under way | Trial under way | Not stated |
| ACT-1 | No | Not stated | 25 recent cases and $2 cases in lead-in phase | Not stated | Not stated | Not stated |
| CREST-2 | Yes | Not defined | >100 | 334 | 153 (46%) | 8311 |
ACST-2, Asymptomatic Carotid Surgery Trial 2; ACT-1, Asymptomatic Carotid Trial; CAS, carotid artery stenting; CREST, Carotid Revascularization Endarterectomy versus Stenting Trial; CREST-2, Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial; EVA-3S, Endarterectomy vs Angioplasty in Patients with Symptomatic Severe Carotid Stenosis; ICSS, International Carotid Stenting Study; SPACE, Stent-Protected Angioplasty vs Carotid Endarterectomy.
Minimal requirements were waived if carotid artery stenting was performed under the supervision of a credentialed interventionist.
Minimal requirements were waived if carotid artery stenting was proctored by an outside interventionist appointed by the trial steering committee.
After completing training, these interventionists proceeded with enrollment in the lead-in phase of CREST. Those with more experience (≥30 cases) performed 5 to 10 procedures in the lead-in phase, and those with less experience (<30 cases) performed 10 to 20 procedures in the lead-in phase (73 exempted because of extensive training and experience).