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RESTORE clinical trials
The RESTORE clinical trials are prospective, multicenter studies to evaluate the safety and effectiveness of the SEISMIQ IVL System for treating severely calcified peripheral arteries, including both above-the-knee (ATK) and below-the-knee (BTK) disease.
These singlearm trials enrolled patients across multiple European sites and assessed outcomes such as procedural success, reduction in diameter stenosis, and freedom from major adverse events. Early results showed the system met its primary endpoints and demonstrated strong safety and performance in challenging lesions.
Feature | ATK1 Intent-to-Treat (ITT) = 95 As Treated (AT) = 95 | BTK2 Intent-to-Treat (ITT) = 20As Treated (AT) = 18 |
Design | ------- Prospective, non-randomized, multicenter study ------- | |
Sites | 10 sites | 3 sites |
IVL Use | 95/95 (100%) | 18/18 (100%) |
| Lesion Characteristics** | ||
Severe Calcification (PARC)‡ | 87 (91.6%) | 15 (83.3%) |
Avg. Lesion Length (mm) | 96.0 ± 37.5 | 68.6 ± 39.6 |
Initial Diameter Stenosis (%) | 93.7 ± 7.2 | 91.4 ± 8.8 |
CTO | 21 (22.1%) | 6 (30.0%)‡ |
Final Diameter Stenosis (%) | 21.2 ± 8.4 | 22.8 ± 11.5 |
Acute Gain (mm) | 3.2 ± 0.9 | 1.3 ± 0.6 |
Procedural Details |
|
|
Pre-Dilatation | 25 (26.3%) | 4 (22.2%) |
Post-Dilatation | 17 (17.9%) | 3 (16.7%) |
Stent | 3 (3.2%) | 0 (0%) |
Primary Safety Endpoint | 100% freedom from MAE at 30 days | 100% freedom from MAE at 30 days |
Primary Efficacy Endpoint | 100% with residual diameter stenosis | 100% with acute reduction in percent diameter stenosis of target lesion |
Conclusion | Met all primary endpoints; | Demonstrated safety and effectiveness |
1. Brodmann M, Schlager O, Werner M, et al. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day and 6-Month Outcomes from the RESTORE ATK Study. Journal of Vascular and Interventional Radiology. doi:10.1016/j.jvir.2026.108695
2. Zeller T, VIVA24, Las Vegas, NV USA, Nov 3-6, 2024.
** As treated group
‡ Calculated by Angiographic Core Lab