Protect IV

Impella® Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial

medical-cross
Heart failure
user
All genders
person-wave 18-90
world
Recruiting now
More information  

Overview
Principal Investigator: Navin Kapur, MD

This is a Prospective, multicenter, randomized, parallel-controlled, open-label two arm trial with an adaptive design. Eligible subjects will be randomized in a 1:1 ratio to PCI with Impella CP® (Intervention Group) versus standard of care PCI with or without IABP (Control Group). Approximately 1252 subjects will be randomized in a 1:1 ratio to PCI + Impella vs. PCI ± IABP.

The objective is to demonstrate that in high-risk patients with complex CAD and reduced left ventricular function undergoing PCI, PCI with Impella MCS is superior to PCI without Impella MCS in reducing the composite rate of all-cause death, stroke, MI or hospitalization for cardiovascular causes at 3-year follow-up.

All subjects will have follow-up for 3 years after randomization. The primary endpoint will be assessed after the last randomized patient reaches 1-year follow-up.

Eligible subjects are those with a chronic coronary syndrome (CCS) or NSTEMI with LVEF  40% or STEMI ≥24 hours and <30 days after symptom onset with LVEF 30% in whom complex PCI is planned after heart team discussion, without any study Exclusion Criteria and who provide informed written consent for participation in the Trial. Prior to randomization, all subjects will undergo baseline transthoracic echocardiography, QoL assessment, 6MWD testing (if able to ambulate). Randomization will take place in the Cardiac Catheterization Lab. Prior to randomization in the Cath Lab, the PCI operator will declare 1) the intended revascularization plan regardless of the use of hemodynamic support (including vessels/lesion, staging and intended IABP use); 2) the intent to use (or not use) IABP if randomized to the Control arm; 3) the planned use of right heart catheterization either within or not within a formal sub-study or not at all. Patients will then be randomized to PCI with Impella CP or standard of care PCI (± IABP),treatment of patients and discontinuation of hemodynamic support will be based on Protocol recommendations and standard of care at the hospital site, but Impella removal in the Cath lab is mandated.

Contact Us

user
Vilma Castaneda, MD

Study details
Inclusion Criteria
  • Local heart team (interventional cardiologist and cardiac surgeon) has determined that PCI is indicated and is the most appropriate management for the patient.
  • Clinical presentation and baseline left ventricular function are as follows: One must be present
    - Subject has CCS or NSTEMI with an LVEF ≤40%
    - Subject has STEMI ≥24 hours and <30 days after symptom onset with an LVEF ≤30%
  • Complex PCI will be performed (specific criteria must met as described in the protocol)
Exclusion Criteria
  • STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present (e.g., VSD, papillary muscle rupture, etc.)
  • Cardiogenic shock (SBP <80 mmHg for ≥30 mins and not responsive to intravenous fluids or requiring pressors or mechanical circulatory support, including IABP)
  • Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for >24 hours with full neurologic recovery)
Study Requirements

Clinical follow-up is performed at 30-days post-discharge and at 6-months, 1-year, 2-years and 3-years post-randomization (+ sweep visit when last subject enrolled reaches 1-year post-randomization follow-up) QoL and costs assessments at baseline, 30-days, 1-year, 3-years 6MWD at baseline, 30-days, 1-year and 3-years Echocardiography at baseline, 6-months, 1-year and 3-years Serum creatinine, BUN at baseline, 30-days, 6-months, 1-year and 3-years BNP or NT-proBNP at baseline, 30-days, 6-months and 1-year