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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 | ATK Intent-to-Treat (ITT) = 95 As Treated (AT) = 95 | BTK 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* | ||
Calcification Severity (PARC) | 91.6% | 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‡ | 32 (33.7%) | 6 (30.0%)1 |
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 |
* As treated group
‡ Calculated by Angiographic Core Lab
1. Preliminary data presented at VEITH 2024 & VIVA 2024: (1) Brodmann, M. (2024). A New More Complex Device for Treating Calcified Arterial Lesions with Lithotripsy (From Bolt Medical: How Does It Work and Advantages, VEITH 2024. (2) Zeller, T (2024) Laser and Optics-Based Peripheral Intravascular Lithotripsy System for the Treatment of Above-the-Knee and Below-the-Knee Calcified Lesions. Results of the RESTORE ATK and RESTORE BTK trials. VIVA 2024.