Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions

  • STATUS
    Recruiting
  • days left to enroll
    10
  • participants needed
    200
  • sponsor
    Herlev and Gentofte Hospital
Updated on 19 February 2024
heart disease
stenosis
exercise test
ischemia
acute coronary syndrome
percutaneous coronary intervention
coronary artery stenosis
coronary disease
antiplatelet therapy
exercise stress test

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.

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.

Details
Condition Coronary Artery Disease, Coronary Artery Disease, Coronary heart disease, Percutaneous Coronary Intervention, Coronary Artery Calcification
Age 18years - 90years
Treatment Lithoplasty, Conventional
Clinical Study IdentifierNCT04253171
SponsorHerlev and Gentofte Hospital
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years and < 90 years
Stable coronary heart disease or non-ST elevation acute coronary syndrome
PCI planned in severely calcified (see definition below), non-occluded, de-novo lesion in native vessel
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

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 <40 %
Renal function with eGFR <30 mL/min
Pregnant or nursing
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.