Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions

Not Applicable

Active, not recruiting

• Conditions: Coronary Artery Calcification; Coronary Artery Disease; Percutaneous Coronary Intervention
• Interventions: Device: Conventional; Device: Lithoplasty

• Registration Number: NCT04253171
• Lead Sponsor: Herlev and Gentofte Hospital

Brief Summary

Severely calcified coronary stenoses are difficult to treat with percutaneous coronary intervention (PCI) using current techniques and there is little specific evidence on how to best treat these cases. It is hypothesized that balloon lithoplasty is superior to conventional balloons for lesion preparation of severely calcified coronary lesions before stent implantation in terms of procedural failure and 1-year target vessel failure.

Detailed Description

Severely calcified coronary stenoses are difficult to treat with percutaneous coronary intervention (PCI) using current techniques. Severe calcifications make it difficult to sufficiently prepare lesions before stenting, to advance stents, and to achieve full stent expansion. There is increased risk of vessel dissection and perforation with angioplasty on severely calcified lesions, and long-term outcomes of PCI are adversely affected. Because severely calcified lesions are often excluded from interventional studies, there is little specific evidence on how to best treat these cases. Only a few randomized studies have specifically explored this question, focusing on the use of rotational atherectomy

Recently, the technique of balloon-based lithoplasty was made commercially available. With this technique, calcifications are cracked with the creation of high-frequency pressure oscillations in a special angioplasty balloon. Standard techniques are used to deliver and dilate the balloon. The method was developed for treatment of otherwise non-dilatable lesions, and first reported results have been encouraging. The lithoplasty device used in the current study (Shockwave IVL, Shockwave Medical, CA, USA) has received CE-mark and post-approval safety has recently been confirmed for treatment of severely calcified coronary lesions in patients.

Besides obvious benefits in non-dilatable lesions for which interventional cardiologists have few other options, it is possible this technique could change the way all severely calcified lesions are treated. Balloon lithoplasty could theoretically crack plates of calcium in the vessel wall in an orderly fashion, which could lead to safer and quicker preparation of severely calcified lesions. Furthermore, a better softening of vessel wall calcium could allow full and symmetric expansion of coronary stents, which could lead to better long-term stent patency.

Study Timeline

• Study First Submitted: 2020-01-28
• Study Start: 2020-01-29
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Primary Completion: 2024-09-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age ≥ 18 years and < 90 years
• Stable coronary heart disease or non-ST elevation acute coronary syndrome
• PCI planned in severely calcified, non-occluded, de-novo lesion in native vessel. Definition of severe calcifications (minimum 1 of 3 (i-iii)); i. Angiography: Radioopacities of the vessel wall visible on cine images before contrast injection on both sides of the vessel lumen in more than one projection. ii. OCT (before lesion preparation): Maximum calcium 1) angle >180 degrees AND 2) thickness 0.5mm, AND 3) longitudinal length >5m m. iii. IVUS (before lesion preparation): Maximum calcium angle >270 degrees.
• Functional evidence of ischemia (non-invasive stress test or fractional flow reserve) in the target vessel territory or stenosis ≥ 90% by visual estimate
• Target vessel reference diameter visually estimated at 2.5-4 mm with ability to pass a 0.014" guidewire across lesion
• Ability to tolerate dual antiplatelet therapy
• Informed consent

Angiographic exclusion criteria:

• Unprotected left main stenosis
• Chronic total occlusion
• Severely calcified bifurcated lesion with expected need to use two stent technique
• Coronary artery dissection

Clinical exclusion criteria

• ST-segment elevation acute myocardial infarction
• Planned later revascularization in non-study lesions
• Planned cardiovascular intervention within 30 days after study intervention
• Clinical instability including decompensated heart disease
• Life expectancy of less than 1 year
• Active peptid ulcer or upper gastrointestinal bleeding within 6 months
• Ongoing systemic infection

Paraclinical exclusion criteria

• Left ventricular ejection fraction <35 %
• Renal function with eGFR <30 mL/min
• Pregnant or nursing

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional lesion preparation	Conventional	Conventional and modified balloons will be used as lesion preparation.
Lithoplasty lesion preparation	Lithoplasty	Balloon lithoplasty will be used as lesion preparation.

Primary Outcome Measures

Name	Time	Method
Number of patients with combined outcome of strategy failure	1 year	Failed stent delivery, residual area stenosis ≥ 20% (OCT-assessed) after PCI, or target vessel failure.; Residual area stenosis will be defined as \[1 - in-stent minimal lumen area/reference area\]. The reference area will be calculated by averaging the proximal and distal reference areas, which will be determined by measuring the lumen contours on most healthy-looking frame of the final OCT in the 0-5 mm edge segments. If a reference cannot be measured on the final OCT, it will be measured on a pre-stent OCT or by using quantitative coronary angiography if pre-stent OCT is unavailable. Target vessel failure will be defined as cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization). Failed or no stent delivery is defined as failure to deliver and deploy 1 or more coronary stents to cover the intended length of the intended target lesion.

Secondary Outcome Measures

Name	Time	Method
Number of patients with composite and components of in-hospital major adverse cardiac events (MACE)	In-hospital	Cardiac death, Any myocardial infarction, Stroke
Number of patients with composite and components of major adverse cardiac events (MACE)	1 year	Cardiac death, Any myocardial infarction, Stroke
Number of patients with in-hospital procedure-related adverse events	In-hospital	Periprocedural myocardial infarction, Coronary dissection (beyond intended by lesion preparation), Coronary perforation/rupture
Number of patients with components of the primary outcome	1 year	Failed stent delivery, Residual area stenosis \>20% (OCT-assessed) after PCI, Target vessel failure
Number of patients with components of target vessel failure	1 year	Cardiac death, Target vessel-related myocardial infarction, Clinically driven target vessel revascularization
OCT outcomes at 1 year procedure	1 year	In-stent late lumen loss
OCT outcomes at index procedure	During procedure	Stent expansion

Trial Locations

Locations (9)

North-Estonia Medical Center; 🇪🇪 Tallinn, Estonia

Gentofte University Hospital; 🇩🇰 Gentofte, Copenhagen, Denmark

University Hospital Leuven; 🇧🇪 Leuven, Belgium

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Aarhus University Hospital Skejby; 🇩🇰 Aarhus, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Trondheim University Hospital; 🇳🇴 Trondheim, Norway

Zealand University Hospital, Roskilde Sygehus; 🇩🇰 Roskilde, Denmark