NCT05003817: CHIP-BCIS3

Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading

Active, enrolled Phase 3 Last updated 9 February 2026

What this trial tests

Phase 3 trial testing Percutaneous left ventricular unloading in Ischemic Heart Disease in 300 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 August 2021

Primary endpoint
3 December 2025

30 June 2026

Quick facts

Lead sponsor	Guy's and St Thomas' NHS Foundation Trust
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	6 August 2021
Primary completion	3 December 2025
Estimated completion	30 June 2026
Sites	1 location across United Kingdom

Drugs / interventions tested

• Percutaneous left ventricular unloading

Conditions studied

• Ischemic Heart Disease — all drugs for Ischemic Heart Disease →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Who can join

18 and older, any sex, with Ischemic Heart Disease or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Over 100,000 coronary stent procedures, where small balloons are used to stretch open a narrowed blood vessel, are performed every year in the United Kingdom to treat people who have conditions such as angina or have suffered a heart attack.

For most patients the risk of complications is low, but for some, there is a higher risk of their heart failing during the procedure. Heart failure is a serious complication which can need treatment with a life support machine and lead to major damage to the heart muscle or even death. These risks are greatest in patients with severely diseased heart arteries and those who already have weakened heart muscle.

A new technology may be able to help with this problem. It consists of a small heart pump which is placed in the heart's main pumping chamber (the left ventricle, LV). This pump is known as a LV unloading device. The LV unloading device is inserted into the heart through a blood vessel in the leg and supports the heart muscle. It is removed at the end of the procedure or when the heart can pump safely on its own. Whilst this heart pump is promising, it comes with some risks of its own. These include bleeding and damage to the arteries in the legs. It is also expensive, costing £8,000 per operation. Currently, there is no strong evidence to guide the use of this device.

The CHIP-BCIS3 study aims to determine whether these heart pumps are beneficial and cost-effective in patients receiving a stenting procedure who are at high-risk of complications.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Review of the Impella Devices.
   Zein R, Patel C, Mercado-Alamo A, Schreiber T, et al · · 2022 · cited 61× · PMID 35474971 · DOI 10.15420/icr.2021.11
2. Comparative Effectiveness of Percutaneous Microaxial Left Ventricular Assist Device vs Intra-Aortic Balloon Pump or No Mechanical Circulatory Support in Patients With Cardiogenic Shock.
   Almarzooq ZI, Song Y, Dahabreh IJ, Kochar A, et al · · 2023 · cited 36× · PMID 37342056 · DOI 10.1001/jamacardio.2023.1643
3. PCI in Patients With Heart Failure: Current Evidence, Impact of Complete Revascularization, and Contemporary Techniques to Improve Outcomes.
   Ahmad Y, Petrie MC, Jolicoeur EM, Madhavan MV, et al · · 2022 · cited 14× · PMID 39132568 · DOI 10.1016/j.jscai.2022.100020
4. Percutaneous Left Ventricular Unloading During High-Risk Coronary Intervention: Rationale and Design of the CHIP-BCIS3 Randomized Controlled Trial.
   Ryan M, Ezad SM, Webb I, O'Kane PD, et al · · 2024 · cited 12× · PMID 38410944 · DOI 10.1161/circinterventions.123.013367
5. Science of left ventricular unloading.
   Meani P, Todaro S, Veronese G, Kowalewski M, et al · · 2025 · cited 6× · PMID 39058419 · DOI 10.1177/02676591241268389
6. Revascularisation for Ischaemic Cardiomyopathy.
   Li Kam Wa ME, Assar SZ, Kirtane AJ, Perera D. · · 2023 · cited 6× · PMID 37655258 · DOI 10.15420/icr.2023.06
7. Mechanical Circulatory Support for Complex High-risk Percutaneous Coronary Intervention.
   Truesdell AG, Davies R, Eltelbany M, Megaly M, et al · · 2023 · cited 4× · PMID 39493941 · DOI 10.15420/usc.2022.26
8. Left Ventricular Unloading in High-Risk Percutaneous Coronary Intervention.
   Perera D, Ryan M, Ezad SM, Khan SQ, et al · · 2026 · cited 2× · PMID 41910380 · DOI 10.1056/nejmoa2515704