Table 4 Procedural safety endpoints
Primary Safety Endpoints | UFE (n = 70) | PAE (n = 16) | LT (n = 7) | OHT (n = 6) | All Subjects (n = 99) |
|---|---|---|---|---|---|
SAE within 30 days | |||||
Death | 1.4%a | 0.0% | 14.3%b | 0.0% | 2.0% |
Myocardial infarct | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
Symptomatic stroke | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
Hand Ischemia | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
Secondary Safety Endpoints | |||||
Immediate, trans-procedure | |||||
Radial artery spasm | 7.1% | 6.3% | 28.6% | 16.7% | 9.1% |
Radial artery dissection | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
Forearm artery perforation | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
RA-specific complications within 30 days | |||||
Hematoma at the puncture sitec | 5.7% | 12.5% | 14.3% | 16.7% | 8.1% |
Symptomatic RA occlusion | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
AV Fistula | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
Pseudoaneurysm | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
Distal embolism | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
Finger amputation/loss of limb | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
Surgical/endovascular intervention | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |