Trials / Recruiting
RecruitingNCT07053618
Interventional Left Ventricular Assist System for PCI in CHIP Patients
Interventional Left Ventricular Assist System for PCI in CHIP Patients: a Prospective, Multicenter, Noninferiority Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 286 (estimated)
- Sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
Mechanical circulatory support (MCS) is a life-sustaining therapy first introduced in the 1950s. After six decades of development, it now serves as a critical bridge therapy for patients with acute cardiac events and end-stage heart failure. Percutaneous mechanical circulatory support (pMCS), a key MCS modality, has advanced rapidly in recent years. In China, pMCS adoption has accelerated significantly, evidenced by year-over-year growth in both specialized centers and clinical cases, alongside continuous technological refinement. Common pMCS devices include: Intra-Aortic Balloon Pump (IABP), Axial flow pump systems (e.g., Impella®), Extracorporeal Membrane Oxygenation (ECMO). However, no randomized study has compared Impella with VA-ECMO in CHIP patients. The aim of the study is to evaluate the effectiveness and safety of interventional left ventricular assist system (VADLINK) compared to the VA-ECMO in providing circulatory support for complicated and high-risk patient with indications for PCI.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implantation of the VADLINK Percutaneous Left Ventricular Assist Device | To implant VADLINK percutaneous left ventricular assist device during percutaneous coronary intervention (PCI). |
| DEVICE | VA-ECMO | Received venous arterial extracorporeal membrane oxygenation (VA-ECMO) during PCI. |
Timeline
- Start date
- 2025-08-06
- Primary completion
- 2026-12-01
- Completion
- 2027-08-01
- First posted
- 2025-07-08
- Last updated
- 2025-08-26
Locations
15 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07053618. Inclusion in this directory is not an endorsement.