Table II.
Approval of interventionists to enroll patients in the stenting trial of the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) according to review cycle
| No. (%) | |
|---|---|
| First review (n = 334) | |
| Approved | 30 (9) |
| Conditionally approveda | 246 (74) |
| Denied or deferredb | 58 (17) |
| Second review (n = 160) | |
| Approved | 85 (53) |
| Conditionally approved | 42 (26) |
| Denied or deferred | 33 (21) |
| Third review (n = 49) | |
| Approved | 35 (71) |
| Conditionally approved | 4 (8) |
| Denied or deferred | 10 (20) |
| Fourth review (n = 3) | |
| Approved | 1 (33) |
| Conditionally approved | 1 (33) |
| Denied or deferred | 1 (33) |
| Fifth review (n = 2) | |
| Approved | 2 (100) |
| Conditionally approved | 0 (0) |
| Denied or deferred | 0 (0) |
| Any review (n = 334)Any | |
| Approved | 153 (46) |
| Denied | 181 (54) |
a
Conditionally approved is defined as operators who were approved pending submission of specified number of additional cases (range, 5–20).
b
Denied or deferred is defined as operators who were not approved or conditionally approved because of lack of experience, low case volume, or questionable technique or the committee was awaiting documentation of experience at time of the review.