Trials / Not Yet Recruiting
Not Yet RecruitingNCT06357026
Phitys I™ Percutaneous Left Ventricular Assist System Study
The Safety and Efficacy of the Percutaneous Left Ventricular Assist System for Intraoperative Circulatory Support During High-risk Percutaneous Coronary Intervention (PCI): a Prospective, Multi-center, Randomized Controlled Study
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 344 (estimated)
- Sponsor
- Shanghai NewMed Medical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI.
Detailed description
This prospective, multi-center, randomized controlled clinical trial of the Percutaneous Ventricular Assist System is designed to measure the incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days after PCI.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Percutaneous Ventricular Assist System（Phigine Medical） | Percutaneous Ventricular Assist System or IABP provides intraoperative circulatory support during high-risk PCI. |
| DEVICE | intra-aortic balloon pump (IABP) | IABP provides intraoperative circulatory support during high-risk PCI. |
Timeline
- Start date
- 2024-04-01
- Primary completion
- 2025-05-01
- Completion
- 2026-04-01
- First posted
- 2024-04-10
- Last updated
- 2024-04-10
Locations
8 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06357026. Inclusion in this directory is not an endorsement.