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Coronary Artery CalcificationNCT04319666

Intravascular Balloon Lithotripsy in Left Main Stem Percutaneous Coronary Intervention

A study testing Left main stenting with intravascular lithotripsy in people with Coronary Artery Calcification and Left Main Coronary Artery Disease, run by St George's, University of London at 6 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The IVL Left Main study is a prospective non-randomised pilot study to investigate the mechanical and procedural outcomes and safety of distal left main stenting with coronary lithotripsy in addition to standard techniques in patients with calcific left main disease and a clinical indication for revascularisation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Left main stenting with intravascular lithotripsy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
6 sitesUnited Kingdom
Study dates
1 May 2020to 1 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

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

  • Subject is ≥ 18 years old.
  • Unprotected distal LM (or equivalent) disease defined as:
  • >70% diameter stenosis (DS) on angiography in the distal LM; or
  • ≥50% DS in the distal LM with a) non-invasive evidence of ischaemia referable to a hemodynamically significant left main lesion, and/or b) FFR ≤0.80; or
  • >70% diameter stenosis in either the ostial left anterior descending (LAD) or ostial left circumflex (LCX) that is within 10 mm of the ostium and requires stenting back into the LM (distal LM equivalent); or
  • >50% diameter stenosis in either the ostial left anterior descending (LAD) or ostial left circumflex (LCX) that is within 10 mm of the ostium and requires stenting back into the LM (distal LM equivalent) with a) non-invasive evidence of ischaemia referable to its myocardial territory and/or b) FFR ≤0.80
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  • Clinical indication for revascularisation by PCI
  • Viability of the treatment vessel as determined by echocardiography, cardiac MRI or other equivalent imaging modality.
  • ≥ 270° arc of calcification within at least one stenotic segment demonstrated on intravascular imaging.
  • Ability to pass a 0.014" guide wire across the lesion.
  • Ability to provide informed consent and comply with all study procedures, including follow-up at 30 days.
  • Lesions not related to the distal LM requiring PCI can be treated:
  • at the time of the study procedure if completed prior to distal LM PCI and the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis <30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation. In situations where the distal LM lesion is critical, the LM can be ballooned or treated first so long as the study protocol is not deviated.
  • as a staged procedure either within the same hospital admission or within 30 days. Any staged procedure must be declared at the index procedure otherwise it will be recorded as an event.

Who cannot join

  • Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
  • Daughter vessel reference diameter < 2.5 mm.
  • Use of rotational atherectomy, scoring or cutting balloon, or any investigational device.
  • Evidence of aneurysm in target vessel within 10 mm of the target lesion.
  • Prior PCI of the LM or PCI of the proximal LAD or proximal LCX within 10 mm of the ostium.
  • Prior coronary artery by-pass graft (CABG) surgery.
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  • Chronic total occlusion (CTO) of the LM, proximal LAD or proximal LCX.
  • Untreated pre-procedural haemoglobin < 8 g/dL.
  • Renal failure with serum creatinine > 2.5 mg/dL and not on chronic dialysis.
  • Uncontrolled diabetes defined as a HbA1c >10%.
  • Coagulopathy manifested by platelet count < 50,000/ mL or International Normalized ratio (INR) > 1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrolment).
  • Cardiogenic shock.
  • Ongoing ST elevation myocardial infarction (STEMI).
  • History of stroke or transient ischemic attack (TIA) within 3 months.
  • NYHA class IV heart failure or LVEF < 20%.
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months.
  • Patients with a life expectancy of less than 1 year.
  • Visible thrombus (by angiography) at target lesion site.
  • Patient has active systemic infection on the day of the index procedure with either fever or requiring intravenous antibiotics.
  • Patient has vascular connective tissue disease (e.g. Marfan's syndrome).
  • Patient has a hypercoagulable disorder.
  • Patient has allergy to imaging contrast media for which they cannot be pre-medicated.
  • Allergy to Aspirin.
  • Allergy to Clopidogrel, Ticagrelor and Prasugrel.
  • Allergy to any component of the drug eluting stent that is planned for use.
  • Patient has any other severe comorbidity that is felt to preclude enrolment by the investigator.
  • Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrolment).

Trial locations and contacts

6 sites in 1 country.

Claudia Cosgrove contact

02087252807

Claudia.Cosgrove@nhs.net

Giovanna Bonato contact

02087252807

gbonato@sgul.ac.uk

6 sites in 1 country

United Kingdom6 sites

  • Belfast Health & Social Care Trust

    Belfast, Northern Ireland

    Simon Walsh, simon.j.walsh@btinternet.com

  • University Hospitals Bristol NHS Foundation Trust

    Bristol

    Julian Strange, Julian.Strange@UHBristol.nhs.uk

  • Golden Jubilee Hospital

    Clydebank, Scotland

    Margaret McEntagert, margaret.mcentegart@nhs.net

  • King's College Hospital NHS Foundation Trust

    London

    Ian Webb, IanWebb@nhs.net

  • Royal Brompton & Harefield NHS Foundation Trust

    London

    Jonathan Hill, J.Hill@rbht.nhs.uk

  • St George's University Hospitals NHS Foundation Trust

    London

    Claudia Cosgrove, Claudia.Cosgrove@nhs.net

Other trials in United Kingdom

About this study

The IVL Left Main study is a prospective non-randomised pilot study to investigate the mechanical and procedural outcomes and safety of distal left main stenting with coronary lithotripsy in addition to standard techniques in patients with calcific left main disease and a clinical indication for revascularisation.

Being tested
Left main stenting with intravascular lithotripsy
Keywords
Coronary artery disease, Atherosclerosis
Medical subject headings
Coronary Artery Disease, Atherosclerosis

What participants receive

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

  • Left main stenting with intravascular lithotripsyDevice

    Intravascular lithotripsy (IVL) will be used to modify coronary artery calcification prior to stent implantation in left main coronary disease. Intravascular ultrasound (IVUS) will be used pre and post IVL and post stenting.

Study groups in NCT04319666
Study groupRoleWhat they receive
PCI to left main with IVLExperimentalNot described
Receives: Device: Left main stenting with intravascular lithotripsy

What is being measured

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

  1. Primary effectiveness endpoint 1

    Mean MSA (mm2) by segment for segments with obstructive disease and ≥ 270 degrees calcification.

    Measured: Time of procedure

  2. Primary effectiveness endpoint 2

    Incidence of residual area stenosis <50% by segment for segments with obstructive disease and ≥ 270 degrees calcification.

    Measured: Time of procedure

  3. Primary safety endpoint

    Incidence of Major Adverse Cardiac Events (MACE) at 30 days MACE consists of cardiac death, myocardial infarction and target vessel revascularisation

    Measured: 30 days

Secondary outcomes (29)

  1. Minimum stent diameter (MSD) (mm) for segments with obstructive disease and ≥ 270 degrees calcification

    Measured: Time of procedure

  2. Stent symmetry ratio for segments with obstructive disease and ≥ 270 degrees calcification

    Measured: Time of procedure

  3. Stent expansion index (%) for segments with obstructive disease and ≥ 270 degrees calcification

    Measured: Time of procedure

  4. MSA (mm2) for all segments.

    Measured: Time of procedure

  5. MSD (mm) for all segments.

    Measured: Time of procedure

  6. Stent symmetry ratio for all segments.

    Measured: Time of procedure

  7. Stent expansion (%) for all segments.

    Measured: Time of procedure

  8. Device crossing success

    ARC-2 criteria

    Measured: Time of procedure

  9. Angiographic success

    ARC-2 criteria

    Measured: Time of procedure

  10. Procedural success

    ARC-2 criteria

    Measured: Time of procedure

  11. Serious angiographic complications

    ARC-2 criteria. Composite of loss of major vessel/side branch, embolisation, disruption of collateral flow, persistent slow-flow or no reflow, major dissection, new regional wall motion abnormality, imaging evidence of loss of viable myocardium.

    Measured: 24-48 hours

  12. MACE at 12 months

    Measured: 12 months

  13. Individual components of MACE at 30 days

    Measured: 30 days

  14. Individual components of MACE at 12 months

    Measured: 12 months

  15. Canadian Cardiovascular Society (CCS) angina status at 30 days

    Measured: 30 days

  16. Canadian Cardiovascular Society (CCS) angina status at 12 months

    Measured: 12 months

  17. Stroke at 30 days

    Measured: 30 days

  18. Stroke at 12 months

    Measured: 12 months

  19. Target lesion failure (TLF) at 30 days

    Measured: 30 days

  20. Target lesion failure (TLF) at 12 months

    Measured: 12 months

  21. Target vessel failure (TVF) at 30 days

    Measured: 30 days

  22. Target vessel failure (TVF) at 12 months

    Measured: 12 months

  23. All-cause mortality

    Stratified by i) cardiac death ii) non-cardiac death

    Measured: 12 months

  24. Peri-procedural myocardial infarction

    ARC-2 criteria

    Measured: 48 hours

  25. Spontaneous myocardial infarction

    ARC-2 criteria

    Measured: 12 months

  26. Ischaemic-driven revascularisation

    Measured: 12 months

  27. All revascularisation

    Measured: 12 months

  28. Angiographic and intracoronary imaging predictors of mechanical and procedural outcomes

    Measured: 12 months

  29. Correlation between CK-MB and/or troponin levels post-PCI and outcomes at 30-days and 12 months

    Measured: 12 months

Timeline

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

  1. First posted24 Mar 2020
  2. Study start1 May 2020 (estimated)
  3. Primary completion1 Mar 2022 (estimated)
  4. Study completion1 Mar 2022 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04319666
Sponsor's protocol ID
2019.0329
Status last verified
Mar 2020
First submitted
27 Feb 2020
Last updated
24 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cosgrove CS, Bajaj R, Malhotra G, Joshi FR, Maehara A, McNeice A, McEntegart M, Ong G, Sidik N, Strange JW, Walsh S, Webb I, Wilson S, Wu J, Spratt JC. Intravascular Lithotripsy in Left Main Stem Percutaneous Coronary Intervention. Catheter Cardiovasc Interv. 2026 Oct 7. doi: 10.1002/ccd.70927. Online ahead of print.

    PubMed 42842313

Questions about this trial

What is this clinical trial studying?

A study testing Left main stenting with intravascular lithotripsy in people with Coronary Artery Calcification and Left Main Coronary Artery Disease, run by St George's, University of London at 6 sites in United Kingdom.

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 14 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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.

Are results available for this study?

Results are not available in the source record.

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

Contact Claudia Cosgrove (02087252807, Claudia.Cosgrove@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary effectiveness endpoint 1 (time frame: Time of procedure). The study lists 3 primary outcomes in all. 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 NCT04319666, which also lists 1 linked publication.

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 24 Mar 2020.

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