Ischemic Heart DiseasePhase 3CHIP-BCIS3NCT05003817

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

A Phase 3 study testing Percutaneous left ventricular unloading in people with Ischemic Heart Disease and Coronary Artery Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ischemic Heart Disease, Coronary Artery Disease
What is being tested?: Percutaneous left ventricular unloading
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteUnited Kingdom
Study dates: 6 Aug 2021to 31 Dec 2026
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Extensive coronary disease defined by a British Cardiovascular Intervention Society (BCIS) Jeopardy Score ≥ 8*
Severe left ventricular systolic dysfunction defined as a LVEF ≤ 35% (or ≤ 45% in the presence of severe mitral regurgitation)#
Complex PCI defined by the presence of at least one of the following criteria:
Unprotected left main intervention in the presence of
an occluded dominant right coronary artery, or
a left dominant circulation, or

Show all 15Show fewer

disease involving the entire bifurcation (Medina 1,1,1 or 0,1,1)
Intended calcium modification (by rotational or orbital atherectomy, lithotripsy or laser)
in multiple vessels or
in the left main stem, or
in a final patent conduit, or
where the anatomic SYNTAX score is ≥32
Target vessel is a chronic total occlusion with planned retrograde approach
In general, patients who do not have bypass grafts will be eligible if the patient has at least proximal left anterior descending (LAD) disease or at least proximal 2 vessel disease. For patients with patent bypass grafts, or in cases where the extent of coronary artery disease (CAD) is uncertain, the BCIS-1 JS should be calculated. The maximum possible JS score is 12. N.B. The JS should be based on all coronary disease, not just the vessel subtending viable myocardium.
Biplane / 3D echocardiography, or cardiac MRI can be used to assess the qualifying LVEF.

Who cannot join

Cardiogenic shock or acute STEMI at randomisation (including current treatment with a mechanical circulatory support device)
Contraindication to pLVAD insertion
Inability to give informed consent
Previously enrolled in CHIP or current enrolment in another interventional study that may affect CHIP outcomes

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH

Other trials in United Kingdom

About this study

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.

Conditions: Ischemic Heart Disease, Coronary Artery Disease
Being tested: Percutaneous left ventricular unloading
Keywords: percutaneous coronary intervention, percutaneous left ventricular unloading
Medical subject headings: Myocardial Ischemia, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Percutaneous left ventricular unloadingDevice
Percutaneous left ventricular unloading involves the placement of a mechanical pump which draws blood from the left ventricle and returns it into the aorta at flow rates approaching native cardiac output.

Study groups in NCT05003817
Study group	Role	What they receive
LV-unloading	Experimental	Participants in the elective unloading (intervention) group will have a percutaneous left ventricular unloading device (pLVAD) inserted at the start of the procedure, before the coronary intervention. Maximal support will be provided throughout the procedure, following which support will be weaned and the device removed should the patient remain haemodynamically stable. Receives: Device: Percutaneous left ventricular unloading
Standard of Care	No intervention	Participants in the control arm will receive the planned high-risk percutaneous coronary intervention as is the current standard of care without elective left ventricular unloading. Alternative mechanical circulatory support devices (such as the intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO) will only be permitted in case of complications.

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite hierarchical outcome analysed using a Win Ratio method.
Events included in the composite hierarchical outcome include: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction.
Measured: Minimum 12-months of follow-up, up to 51 months

Secondary outcomes (14)

Individual components of the primary outcome including: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial injury.
Analysis will include repeated occurrences of these events
Measured: Minimum 12-months of follow-up, up to 51 months
Completeness of revascularisation measured by the change in anatomic BCIS-JS score
Measured: Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year
Completeness of revascularisation measured by the change in anatomic SYNTAX score
Measured: Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year
Major bleeding using the Bleeding Academic Research Consortium (BARC 3 to 5) classification
Measured: At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up
Vascular complication measured using VARC criteria
Measured: Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year
Procedural complication measured as the incidence of VT/VF requiring defibrillation, cardiorespiratory arrest, acute pulmonary oedema requiring assisted ventilation or prolonged hypotension
Measured: Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year
Unplanned revascularisation
Measured: At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up
Health-related quality of life and functional status measured by the EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L)
The EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L) measures quality of life and functional status with higher scores indicating better outcomes.
Measured: At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up
Resource utilisation and cost effectiveness measured by incremental costs
Measured: At 12-months post-randomisation
Resource utilisation and cost effectiveness measured by quality-adjusted life years (QALYs)
Measured: At 12-months post-randomisation
Resource utilisation and cost effectiveness measured by net monetary benefit
Measured: At 12-months post-randomisation
Acute kidney injury
Defined as prolongation hospital admission or readmission ≥ 24 hours with rise in creatinine to 200% of baseline value or need for new renal replacement therapy within 30 days of procedure
Measured: At 90 days post-randomisation
Serial cardiac troponin (T or I) levels
Measured by immunoassay
Measured: At baseline, 6 and 24 hours post-procedure
Length of stay
Measured by the duration of admission in complete days following the index PCI procedure and any subsequent planned staged PCI procedure
Measured: Up to a maximum of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Aug 202131 Dec 2026

First posted12 Aug 2021
Study start6 Aug 2021
Primary completion3 Dec 2025
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05003817
Sponsor's protocol ID: IRAS290599
Other IDs: 130593, 17730734
Acronym: CHIP-BCIS3
Status last verified: Feb 2026
First submitted: 21 Jul 2021
Last updated: 10 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Ryan M, Ezad SM, Webb I, O'Kane PD, Dodd M, Evans R, Laidlaw L, Khan SQ, Weerackody R, Bagnall A, Panoulas VF, Rahman H, Strange JW, Fath-Ordoubadi F, Hoole SP, Stables RH, Curzen N, Clayton T, Perera D; CHIP-BCIS3 Investigators. Percutaneous Left Ventricular Unloading During High-Risk Coronary Intervention: Rationale and Design of the CHIP-BCIS3 Randomized Controlled Trial. Circ Cardiovasc Interv. 2024 Mar;17(3):e013367. doi: 10.1161/CIRCINTERVENTIONS.123.013367. Epub 2024 Feb 27.
PubMed 38410944
Ezad SM, Ryan M, Khan SQ, Panoulas VF, Ladwiniec A, Keeble T, Webb I, Shaukhat A, Hinton J, Li Kam Wa ME, Sinha A, Morgan H, De Silva K, Pavlidis A, Spratt J, Johnson T, Walsh S, Banning AP, Hildick-Smith D, O'Kane P, Barrett N, Dodd M, Douiri A, Clayton T, Perera D; CHIP-BCIS3 Investigators. Impact of Left Ventricular Unloading on Hemodynamics and Stunning in Complex PCI: A CHIP-BCIS3 Substudy. J Am Coll Cardiol. 2026 Jul 28:S0735-1097(26)07065-8. doi: 10.1016/j.jacc.2026.06.041. Online ahead of print.
PubMed 42554527
Perera D, Ryan M, Ezad SM, Khan SQ, Webb I, O'Kane PD, Weerackody R, Dodd M, Kwok M, Laidlaw L, Van Dyck L, Wrigley B, Strange JW, Bagnall A, Fath-Ordoubadi F, Panoulas VF, Ladwiniec A, Davies JR, Chase A, Owens CG, Watkins S, Rahman H, Pareek N, Rathod K, Rawlins J, Evans R, Hoole SP, Stables RH, Curzen N, Clayton T; CHIP-BCIS3 Investigators. Left Ventricular Unloading in High-Risk Percutaneous Coronary Intervention. N Engl J Med. 2026 May 7;394(18):1779-1789. doi: 10.1056/NEJMoa2515704. Epub 2026 Mar 29.
PubMed 41910380

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading
ClinicalTrials.gov ID: NCT05003817
Acronym / sponsor ID: CHIP-BCIS3 / IRAS290599
Conditions: Ischemic Heart Disease, Coronary Artery Disease
Keywords: percutaneous coronary intervention, percutaneous left ventricular unloading
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 300 participants (actual)
Lead sponsor: Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
Collaborators: London School of Hygiene and Tropical Medicine, The Queen Elizabeth Hospital, The Royal Bournemouth Hospital, St. George's Hospital, London, King's College Hospital NHS Trust, King's College London, Royal Victoria Hospital, Belfast, Bristol Heart Institute, Barts Heart Centre, London, Glenfield Hospital, Leicester, Morriston Hospital, Swansea, St Thomas' Hospital, London, New Cross Hospital, Wolverhampton, Essex Cardiothoracic Centre, Basildon, Freeman Hospital, Newcastle, Golden Jubilee National Hospital, Glasgow, John Radcliffe Hospital, Oxford, Manchester Royal Infirmary, Royal Cornwall Hospital, Truro, Royal Brompton & Harefield NHS Foundation Trust, Musgrove Park Hospital, Taunton, Royal Sussex County Hospital, Brighton
Study start: 6 Aug 2021 (actual)
Primary completion: 3 Dec 2025 (actual)
Study completion: 31 Dec 2026 (estimated)
First posted: 12 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LV-unloading	Experimental	Device: Percutaneous left ventricular unloadingParticipants in the elective unloading (intervention) group will have a percutaneous left ventricular unloading device (pLVAD) inserted at the start of the procedure, before the coronary intervention. Maximal support will be provided throughout the procedure, following which support will be weaned and the device removed should the patient remain haemodynamically stable.
Standard of Care	No intervention	–Participants in the control arm will receive the planned high-risk percutaneous coronary intervention as is the current standard of care without elective left ventricular unloading. Alternative mechanical circulatory support devices (such as the intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO) will only be permitted in case of complications.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Extensive coronary disease defined by a British Cardiovascular Intervention Society (BCIS) Jeopardy Score ≥ 8*
Severe left ventricular systolic dysfunction defined as a LVEF ≤ 35% (or ≤ 45% in the presence of severe mitral regurgitation)#
Complex PCI defined by the presence of at least one of the following criteria:

Key exclusion criteria (4 listed)

Cardiogenic shock or acute STEMI at randomisation (including current treatment with a mechanical circulatory support device)
Contraindication to pLVAD insertion
Inability to give informed consent
Previously enrolled in CHIP or current enrolment in another interventional study that may affect CHIP outcomes

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Percutaneous left ventricular unloadingPercutaneous left ventricular unloading involves the placement of a mechanical pump which draws blood from the left ventricle and returns it into the aorta at flow rates approaching native cardiac output.	Device	LV-unloading

Primary outcome

Composite hierarchical outcome analysed using a Win Ratio method.
Time frame: Minimum 12-months of follow-up, up to 51 months
Events included in the composite hierarchical outcome include: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction.

14 secondary outcomes

Individual components of the primary outcome including: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial injury.
Time frame: Minimum 12-months of follow-up, up to 51 months
Completeness of revascularisation measured by the change in anatomic BCIS-JS score
Time frame: Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year
Completeness of revascularisation measured by the change in anatomic SYNTAX score
Time frame: Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year
Major bleeding using the Bleeding Academic Research Consortium (BARC 3 to 5) classification
Time frame: At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up
Vascular complication measured using VARC criteria
Time frame: Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year
Procedural complication measured as the incidence of VT/VF requiring defibrillation, cardiorespiratory arrest, acute pulmonary oedema requiring assisted ventilation or prolonged hypotension
Time frame: Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year
Unplanned revascularisation
Time frame: At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up
Health-related quality of life and functional status measured by the EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L)
Time frame: At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up
Resource utilisation and cost effectiveness measured by incremental costs
Time frame: At 12-months post-randomisation
Resource utilisation and cost effectiveness measured by quality-adjusted life years (QALYs)
Time frame: At 12-months post-randomisation
Resource utilisation and cost effectiveness measured by net monetary benefit
Time frame: At 12-months post-randomisation
Acute kidney injury
Time frame: At 90 days post-randomisation
Serial cardiac troponin (T or I) levels
Time frame: At baseline, 6 and 24 hours post-procedure
Length of stay
Time frame: Up to a maximum of 1 year

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Background: PubMed 38410944Ryan M, Ezad SM, Webb I, O'Kane PD, Dodd M, Evans R, Laidlaw L, Khan SQ, Weerackody R, Bagnall A, Panoulas VF, Rahman H, Strange JW, Fath-Ordoubadi F, Hoole SP, Stables RH, Curzen N, Clayton T, Perera D; CHIP-BCIS3 Investigators. Percutaneous Left Ventricular Unloading During High-Risk Coronary Intervention: Rationale and Design of the CHIP-BCIS3 Randomized Controlled Trial. Circ Cardiovasc Interv. 2024 Mar;17(3):e013367. doi: 10.1161/CIRCINTERVENTIONS.123.013367. Epub 2024 Feb 27.
Derived from this study: PubMed 42554527Ezad SM, Ryan M, Khan SQ, Panoulas VF, Ladwiniec A, Keeble T, Webb I, Shaukhat A, Hinton J, Li Kam Wa ME, Sinha A, Morgan H, De Silva K, Pavlidis A, Spratt J, Johnson T, Walsh S, Banning AP, Hildick-Smith D, O'Kane P, Barrett N, Dodd M, Douiri A, Clayton T, Perera D; CHIP-BCIS3 Investigators. Impact of Left Ventricular Unloading on Hemodynamics and Stunning in Complex PCI: A CHIP-BCIS3 Substudy. J Am Coll Cardiol. 2026 Jul 28:S0735-1097(26)07065-8. doi: 10.1016/j.jacc.2026.06.041. Online ahead of print.
Derived from this study: PubMed 41910380Perera D, Ryan M, Ezad SM, Khan SQ, Webb I, O'Kane PD, Weerackody R, Dodd M, Kwok M, Laidlaw L, Van Dyck L, Wrigley B, Strange JW, Bagnall A, Fath-Ordoubadi F, Panoulas VF, Ladwiniec A, Davies JR, Chase A, Owens CG, Watkins S, Rahman H, Pareek N, Rathod K, Rawlins J, Evans R, Hoole SP, Stables RH, Curzen N, Clayton T; CHIP-BCIS3 Investigators. Left Ventricular Unloading in High-Risk Percutaneous Coronary Intervention. N Engl J Med. 2026 May 7;394(18):1779-1789. doi: 10.1056/NEJMoa2515704. Epub 2026 Mar 29.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Divaka Perera principal investigator

KCL, GSTT

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite hierarchical outcome analysed using a Win Ratio method. (time frame: Minimum 12-months of follow-up, up to 51 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05003817, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.