Trials / Active Not Recruiting
Active Not RecruitingNCT07010965
SAVE-PCI: NyokAssist™ Small-Bore VAD vs. IABP in Elective High-Risk PCI
SAVE-PCI is a Prospective, Multi-center, Randomized Controlled Trial Evaluating the Safety and Efficacy of NyokAssist™ , a Small-bore Percutaneous Ventricular Assist Device (pVAD), in Comparison With Intra-aortic Balloon Pump (IABP) in Patients Undergoing Elective High-risk Percutaneous Coronary Intervention (PCI)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 236 (actual)
- Sponsor
- magAssist, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
SAVE-PCI is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with intra-aortic balloon pump (IABP) in patients undergoing elective high-risk percutaneous coronary intervention (PCI).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NyokAssist™ | The NyokAssist™ Ventricular Assist Device can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta . |
| DEVICE | IABP Intra-aortic balloon pump | IABP uses counterpulsation to provide coronary flow |
Timeline
- Start date
- 2024-07-31
- Primary completion
- 2025-11-21
- Completion
- 2026-01-31
- First posted
- 2025-06-08
- Last updated
- 2026-01-12
Locations
12 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07010965. Inclusion in this directory is not an endorsement.