Clinical trial NCT04319666: Intravascular Balloon Lithotripsy in Left Main Stem Percutaneous Coronary Intervention
Official title: Intravascular Balloon Lithotripsy in Left Main Stem Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Calcification
Left Main Coronary Artery Disease
Keywords: Coronary artery disease
Atherosclerosis
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: St George's University Hospitals NHS Foundation Trust
name: Shockwave Medical, Inc.
First posted: 2020-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Primary effectiveness endpoint 1
timeFrame: Time of procedure
measure: Primary effectiveness endpoint 2
timeFrame: Time of procedure
measure: Primary safety endpoint
timeFrame: 30 days
Secondary outcomes:
measure: Minimum stent diameter (MSD) (mm) for segments with obstructive disease and ≥ 270 degrees calcification
timeFrame: Time of procedure
measure: Stent symmetry ratio for segments with obstructive disease and ≥ 270 degrees calcification
timeFrame: Time of procedure
measure: Stent expansion index (%) for segments with obstructive disease and ≥ 270 degrees calcification
timeFrame: Time of procedure
measure: MSA (mm2) for all segments.
timeFrame: Time of procedure
measure: MSD (mm) for all segments.
timeFrame: Time of procedure
measure: Stent symmetry ratio for all segments.
timeFrame: Time of procedure
measure: Stent expansion (%) for all segments.
timeFrame: Time of procedure
measure: Device crossing success
timeFrame: Time of procedure
measure: Angiographic success
timeFrame: Time of procedure
measure: Procedural success
timeFrame: Time of procedure
measure: Serious angiographic complications
timeFrame: 24-48 hours
measure: MACE at 12 months
timeFrame: 12 months
measure: Individual components of MACE at 30 days
timeFrame: 30 days
measure: Individual components of MACE at 12 months
timeFrame: 12 months
measure: Canadian Cardiovascular Society (CCS) angina status at 30 days
timeFrame: 30 days
measure: Canadian Cardiovascular Society (CCS) angina status at 12 months
timeFrame: 12 months
measure: Stroke at 30 days
timeFrame: 30 days
measure: Stroke at 12 months
timeFrame: 12 months
measure: Target lesion failure (TLF) at 30 days
timeFrame: 30 days
measure: Target lesion failure (TLF) at 12 months
timeFrame: 12 months
measure: Target vessel failure (TVF) at 30 days
timeFrame: 30 days
measure: Target vessel failure (TVF) at 12 months
timeFrame: 12 months
measure: All-cause mortality
timeFrame: 12 months
measure: Peri-procedural myocardial infarction
timeFrame: 48 hours
measure: Spontaneous myocardial infarction
timeFrame: 12 months
measure: Ischaemic-driven revascularisation
timeFrame: 12 months
measure: All revascularisation
timeFrame: 12 months
measure: Angiographic and intracoronary imaging predictors of mechanical and procedural outcomes
timeFrame: 12 months
measure: Correlation between CK-MB and/or troponin levels post-PCI and outcomes at 30-days and 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast Health & Social Care Trust
state: Northern Ireland
city: Clydebank
country: United Kingdom
facility: Golden Jubilee Hospital
state: Scotland
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Brompton & Harefield NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
Study officials:
affiliation: St George's University Hospitals NHS Foundation Trust
name: James Spratt
role: PRINCIPAL_INVESTIGATOR
References: