Jetstream™
Atherectomy System
Study Design
172 patients with the following inclusion criteria:
- Documented symptomatic atherosclerotic peripheral vascular disease
- Target lesion(s) in a superficial femoral, popliteal, and/or infrapopliteal artery
- Reference vessel lumen proximal to target lesion >3.0 and <5.0 mm in diameter by visual estimation
- Stenosis >70% and crossable with a guidewire
- Single or multiple focal stenosis up to 10 cm long in the femoropopliteal segment or up to 3 cm long in the tibial or peroneal arteries
Study Device
Lesion Characteristics
| Lesion Location | |
| SFA | 134/210 (64%) |
| Popliteal artery | 58/210 (28%) |
| Tibial artery | 18/210 (9%) |
| Lesion length, mm | 27.4±23.9 (3.0–100.0) 95% CI 24.2 to 30.7 |
| SFA (n=134) | 29.9±26.2 (5.0–100.0) 95% CI 25.4 to 34.4 |
| Anterior tibial (n=2) | 22.5±10.6 (15.0–30.0) 95% CI 272.8 to 117.8 |
| TPT (n=13) | 13.9±8.9 (3.0–30.0) 95% CI 8.5 to 19.3 |
| Posterior tibial (n=1) | 15.0 |
| Popliteal (n=57*) | 25.8±19.8 (3.0–100.0) 95% CI 20.5 to 31.0 |
| Peroneal (n=2) | 10.0±0.0 (10.0–10.0) |
| Moderate to high calcium | 108/210 (51%) |
| Total occlusions | 64/208 (31%) |
| Reference vessel diameter, mm | 4.5±0.6 (3.0–6.0) 95% CI 4.4 to 4.6 |
| SFA (n=134) | 4.6±0.5 (3.5–5.5) 95% CI 4.6 to 4.7 |
| Anterior tibial (n=2) | 3.0±0.0 (3.0–3.0) |
| TPT (n=13) | 3.7±0.8 (3.0–5.0) 95% CI 3.2 to 4.2 |
| Posterior tibial (n=1) | 3.0 |
| Popliteal (n=58) | 4.5±0.6 (3.5–6.0) 95% CI 4.3 to 4.6 |
| Peroneal (n=2) | 3.0±0.0 (3.0–3.0) |
Endpoints
- Primary safety endpoint: freedom from major adverse events (MAE) including clinically driven target lesion revascularization (TLR), any death, target vessel revascularization (TVR), myocardial infarction (MI), and index limb amputation at 30 days post procedure
- Primary efficacy endpoint: reduction in mean percent stenosis with and without adjunctive therapy
Key Clinical Results
- Device success was 99% (208/210 lesions)
- MAE at 30 days was 1% (2 preplanned amputations)
- Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively
- The ankle-brachial index increased significantly from 0.59±0.21 at baseline to 0.82±0.27 (p<0.05) at 12 months
- Mean Rutherford class improved from 3.0±0.9 at baseline to 1.5±1.3 at 1 year (p<0.05)
Total occlusion of a right superficial femoral artery at (A) baseline, (B) after atherectomy, (C) after adjunctive 5-mm balloon angioplasty, and (D) 30 months post procedure.