Intravascular Balloon Lithotripsy in Left Main Stem Percutaneous Coronary Intervention

Coronary Artery Calcification Clinical Trial

Official title:

Intravascular Balloon Lithotripsy in Left Main Stem Percutaneous Coronary Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04319666
• Other study ID #: 2019.0329
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2020
• Source: St George's, University of London
• Contact: Claudia Cosgrove
• Phone: 02087252807
• Email: Claudia.Cosgrove[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is = 18 years old.

• Unprotected distal LM (or equivalent) disease defined as:

1. >70% diameter stenosis (DS) on angiography in the distal LM; or

2. =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

3. >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

4. >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:

1. 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.

2. 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.

Exclusion Criteria:

• 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%.

• 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).

Related Conditions & MeSH terms

• Coronary Artery Calcification
• Coronary Artery Disease
• Coronary Disease
• Left Main Coronary Artery Disease
• Myocardial Ischemia

Intervention

Device:
• Left main stenting with intravascular lithotripsy
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.

Locations

Country	Name	City	State
United Kingdom	Belfast Health & Social Care Trust	Belfast	Northern Ireland
United Kingdom	University Hospitals Bristol NHS Foundation Trust	Bristol
United Kingdom	Golden Jubilee Hospital	Clydebank	Scotland
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	Royal Brompton & Harefield NHS Foundation Trust	London
United Kingdom	St George's University Hospitals NHS Foundation Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
St George's, University of London	Shockwave Medical, Inc., St George's University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary effectiveness endpoint 1	Mean MSA (mm2) by segment for segments with obstructive disease and = 270 degrees calcification.	Time of procedure
Primary	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	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	Minimum stent diameter (MSD) (mm) for segments with obstructive disease and = 270 degrees calcification		Time of procedure
Secondary	Stent symmetry ratio for segments with obstructive disease and = 270 degrees calcification		Time of procedure
Secondary	Stent expansion index (%) for segments with obstructive disease and = 270 degrees calcification		Time of procedure
Secondary	MSA (mm2) for all segments.		Time of procedure
Secondary	MSD (mm) for all segments.		Time of procedure
Secondary	Stent symmetry ratio for all segments.		Time of procedure
Secondary	Stent expansion (%) for all segments.		Time of procedure
Secondary	Device crossing success	ARC-2 criteria	Time of procedure
Secondary	Angiographic success	ARC-2 criteria	Time of procedure
Secondary	Procedural success	ARC-2 criteria	Time of procedure
Secondary	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.	24-48 hours
Secondary	MACE at 12 months		12 months
Secondary	Individual components of MACE at 30 days		30 days
Secondary	Individual components of MACE at 12 months		12 months
Secondary	Canadian Cardiovascular Society (CCS) angina status at 30 days		30 days
Secondary	Canadian Cardiovascular Society (CCS) angina status at 12 months		12 months
Secondary	Stroke at 30 days		30 days
Secondary	Stroke at 12 months		12 months
Secondary	Target lesion failure (TLF) at 30 days		30 days
Secondary	Target lesion failure (TLF) at 12 months		12 months
Secondary	Target vessel failure (TVF) at 30 days		30 days
Secondary	Target vessel failure (TVF) at 12 months		12 months
Secondary	All-cause mortality	Stratified by i) cardiac death ii) non-cardiac death	12 months
Secondary	Peri-procedural myocardial infarction	ARC-2 criteria	48 hours
Secondary	Spontaneous myocardial infarction	ARC-2 criteria	12 months
Secondary	Ischaemic-driven revascularisation		12 months
Secondary	All revascularisation		12 months
Secondary	Angiographic and intracoronary imaging predictors of mechanical and procedural outcomes		12 months
Secondary	Correlation between CK-MB and/or troponin levels post-PCI and outcomes at 30-days and 12 months		12 months