Impella-Supported PCI for Coronary Heart Disease

(PROTECT IV Trial)

Recruiting at 109 trial locations

Overseen By Adam Thompson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abiomed Inc.

Must not be taking: Anticoagulants

Disqualifiers: Cardiogenic shock, Severe aortic stenosis, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

1252 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on a chronic oral anticoagulant, it must be safely stopped for at least 72 hours before and after the procedure if it's a vitamin K antagonist, or for at least 48 hours if it's a direct acting oral anticoagulant.

What data supports the effectiveness of the treatment Impella-Supported PCI for Coronary Heart Disease?

Research shows that using Impella devices during high-risk heart procedures can help maintain stable blood flow and support heart function, especially in patients with severe heart disease and weak heart muscles. This support can potentially reduce complications during these procedures. ^{1 2 3 4 5}

How does the Impella-supported PCI treatment differ from other treatments for coronary heart disease?

Impella-supported PCI is unique because it uses a small pump to help the heart maintain blood flow during high-risk procedures, which can protect patients with severe coronary artery disease and weak heart function. This approach is different from standard treatments as it provides mechanical support to the heart, reducing the risk of complications during the procedure. ^{1 2 3 4 6}

What is the purpose of this trial?

The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.

Eligibility Criteria

Adults aged 18-90 with complex coronary artery disease, reduced left ventricular function (LVEF ≤40% or ≤30% in specific cases), and planned high-risk PCI. Candidates must not have life-threatening non-cardiac conditions, recent severe heart attacks, cardiogenic shock, pregnancy, or other serious medical issues that could affect participation.

Inclusion Criteria

I had a severe heart attack between 1 to 30 days ago and my heart's pumping ability is very weak.

I have a specific type of heart blockage and plan to have surgery on it and two other areas.

I have severe blockages in all three main heart arteries and plan to have stent placement in at least two.

Exclusion Criteria

I do not have severe heart, blood, or vascular conditions that would exclude me.

Pregnant or child-bearing potential unless negative pregnancy test within 1 week

I had a severe heart attack within the last 24 hours or have complications from a heart attack.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo high-risk PCI with or without the Impella device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• Impella®-Supported PCI

Trial Overview The trial is testing whether using the Impella® devices during high-risk percutaneous coronary intervention (PCI) improves symptoms and heart function compared to standard care with an intra-aortic balloon pump in patients with significant heart vessel blockage and weakened heart pumping ability.

Participant Groups

Group I: Impella Arm Experimental Treatment 1 Intervention

Impella CP® or Impella 2.5 placement prior to high-risk PCI

Group II: Control Arm Active Control 1 Intervention

Subjects randomized to the Control group will be treated per standard of care PCI with or without an intra-aortic balloon pump (IABP).

Who Is Running the Clinical Trial?

Abiomed Inc.

Lead Sponsor

Trials

47

Recruited

33,900+

Founded

1981

Headquarters

Danvers, United States

Known For

Heart Recovery Technologies

Top Products

Impella heart pumps, AbioCor, Breethe OXY-1 System

Findings from Research

In a study of 48 high-risk patients with severe coronary artery disease and left ventricle dysfunction, Impella-supported percutaneous coronary interventions (PCIs) led to significant improvements in heart function, with LVEF increasing from 30% to 35% after 6 months.

The reduction in ischemic myocardium burden was substantial, as indicated by a decrease in the British Cardiovascular Intervention Society Jeopardy score, and improvements in wall motion score index were specifically linked to the revascularized heart segments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Impella protected-percutaneous coronary intervention on left ventricle function recovery of patients with extensive coronary disease and poor left ventricular function. Romagnoli, E., Burzotta, F., Cerracchio, E., et al.[2023]

The use of the Impella 2.5 for partial circulatory support during high-risk percutaneous coronary interventions (PCI) in 60 patients showed a high angiographic success rate of 96%, indicating its efficacy in complex cases.

Despite the high-risk profile of patients, including severe heart conditions, the procedure demonstrated safety with only one procedural death and a 30-day mortality rate of 5%, while no major complications like myocardial infarction or stroke occurred.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Impella 2.5 for prophylactic circulatory support during elective high-risk percutaneous coronary intervention. Alasnag, MA., Gardi, DO., Elder, M., et al.[2016]

The Impella LP 2.5 device was safely used in three patients with severely compromised left ventricular function during elective percutaneous coronary intervention (PCI), showing no acute device-related adverse events and improving mean blood pressure without increasing aortic valve regurgitation.

While the procedure was uncomplicated, two patients required additional pharmacologic support, and one patient unfortunately passed away a month later due to worsening heart failure, indicating the need for larger studies to better assess the efficacy of this device in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with the Impella Recover LP 2.5 micro-axial pump in patients undergoing high-risk coronary angioplasty. Thomopoulou, S., Manginas, A., Cokkinos, DV.[2018]

The Impella CP® device provides effective short-term circulatory support during high-risk percutaneous coronary interventions (PCI) in patients with severely depressed left ventricular function, helping to maintain hemodynamic stability.

In two case reports, the use of the Impella CP® device during PCI was associated with a reduction in complications, demonstrating its potential as a safe option for patients with complex coronary lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of Impella in high-risk percutaneous coronary intervention. Moura-Ferreira, S., Ladeiras-Lopes, R., MBala, D., et al.[2021]

In a study of 37 patients with reduced left-ventricular ejection fraction undergoing elective Impella-protected percutaneous coronary intervention, significant drops in blood pressure were observed, but all patients maintained systolic blood pressure above 78 mm Hg, ensuring vital organ perfusion.

Critical drops in blood pressure occurred in 10.8% of patients, particularly in those with higher jeopardy scores indicating more severe coronary artery disease, suggesting that careful monitoring is essential in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamics and its predictors during Impella-protected PCI in high risk patients with reduced ejection fraction. Russo, G., Burzotta, F., D'Amario, D., et al.[2022]

In a study involving 5 high-risk patients with severe coronary artery disease, the use of the Impella mechanical circulatory support device during percutaneous coronary intervention (PCI) was successful, with no complications and all patients remaining alive and well at 30 days post-procedure.

The Impella device effectively unloads the heart, improves blood flow, and reduces oxygen demand, suggesting that its use in high-risk PCI can enhance patient outcomes even in non-surgical centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Risk "Protected" Percutaneous Coronary Intervention with Mechanical Circulatory Support in a Non-Surgical Center - An Early Asian Experience. Li, KFC., Ho, HH., Jafary, FH., et al.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of Impella protected-percutaneous coronary intervention on left ventricle function recovery of patients with extensive coronary disease and poor left ventricular function. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Use of the Impella 2.5 for prophylactic circulatory support during elective high-risk percutaneous coronary intervention. [2016]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Initial experience with the Impella Recover LP 2.5 micro-axial pump in patients undergoing high-risk coronary angioplasty. [2018]

4. Spain pubmed.ncbi.nlm.nih.gov

The role of Impella in high-risk percutaneous coronary intervention. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Hemodynamics and its predictors during Impella-protected PCI in high risk patients with reduced ejection fraction. [2022]

6. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

High-Risk "Protected" Percutaneous Coronary Intervention with Mechanical Circulatory Support in a Non-Surgical Center - An Early Asian Experience. [2020]