Intravascular Balloon Lithotripsy in Left Main Stem Percutaneous Coronary Intervention

NCT04319666 | Unknown

• 1 other identifier: 2019.0329
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Coronary Artery Calcification; Left Main Coronary Artery Disease

Keywords

Coronary artery disease; Atherosclerosis

Outcome Measures

Primary Outcomes (3)

• Primary effectiveness endpoint 1

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

  Time of procedure

• Primary effectiveness endpoint 2

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

  Time of procedure

• Primary safety endpoint

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

  30 days

Secondary Outcomes (29)

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

  Time of procedure

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

  Time of procedure

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

  Time of procedure

• MSA (mm2) for all segments.

  Time of procedure

• MSD (mm) for all segments.

  Time of procedure

Study Arms (1)

PCI to left main with IVL

EXPERIMENTAL

Device: Left main stenting with intravascular lithotripsy

Interventions

Left main stenting with intravascular lithotripsy DEVICE

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.

PCI to left main with IVL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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%.

Sponsors & Collaborators

• St George's, University of London: lead
• St George's University Hospitals NHS Foundation Trust: collaborator
• Shockwave Medical, Inc.: collaborator

Study Sites (6)

Belfast Health & Social Care Trust

Belfast, Northern Ireland, United Kingdom

Location

Golden Jubilee Hospital

Clydebank, Scotland, United Kingdom

Location

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, United Kingdom

Location

Royal Brompton & Harefield NHS Foundation Trust

London, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• James Spratt

  St George's University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Cosgrove

CONTACT

02087252807; Claudia.Cosgrove@nhs.net

Giovanna Bonato

CONTACT

02087252807; gbonato@sgul.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 24, 2020
• Study Start: May 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6)