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Cardiovascular DiseasesLASER EXPANDNCT04359446

Laser-excimer Versus High-pressure Dilation to Treat Under-expansion of the Stent

A study testing NC ( Non- Compliant) Balloon dilatation and Laser Excimer + NC Balloon in people with Cardiovascular Diseases and Arterial Disease, run by Fundación EPIC at 6 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The laser-excimer technology could be an essential tool to correct the under-expansion of the stent once it has been implanted unless severe calcification. The laser-excimer technology achieves a greater minimum luminal area when treating an infra-expanded stent, when compared with the results obtained with the simple… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases, Arterial Disease
What is being tested?
NC ( Non- Compliant) Balloon dilatation and Laser Excimer + NC Balloon
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
6 sitesSpain
Study dates
12 Sep 2020to 28 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with:
  • Age ≥ 18 years.
  • Consecutive real-world patients, referred for cardiac catheterization for any cause, who present in any main vessel, bypass or in the common trunk an under-expanded stent tributary of being treated (minimum luminal area <4 mm2 or <6 mm2 in the left main coronary artery measured by IVUs (Intravascular Ultrasound) / OCT(Optical Coherence Tomography)) and that it is not possible to dilate with a NC balloon to a maximum of 20 atm.

Who cannot join

  • Refusal of the patient to participate in the study.
  • Patients with life expectancy <1 year.
  • Patients with advanced kidney disease (grade IV) or liver failure (Child C)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Spain6 sites

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005

  • Hospital Universitario Lucus Agusti

    Lugo, 27003

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, Coruña, 15706

Other trials in Spain

About this study

Official title: Laser-excimer Versus High-pressure Dilation to Treat Under-expansion of the Stent (LASER EXPAND Study)

The laser-excimer technology could be an essential tool to correct the under-expansion of the stent once it has been implanted unless severe calcification. The laser-excimer technology achieves a greater minimum luminal area when treating an infra-expanded stent, when compared with the results obtained with the simple dilatation at high or very high pressure.

Read the detailed description

The laser-excimer technology could be an essential tool to correct the under-expansion of the stent once it has been implanted unless severe calcification.

The investigators propose a study that serves as proof of concept for this technology (laser Excimer) used according to its intended use in this specific substrate of coronary lesions. (stent under-expansion without severe underlying calcification).The laser-excimer technology achieves a greater minimum luminal area when treating an infra-expanded stent, when compared with the results obtained with the simple dilatation at high or very high pressure.

Being tested
NC ( Non- Compliant) Balloon dilatation, Laser Excimer + NC Balloon
Keywords
LASER EXPAND
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NC ( Non- Compliant) Balloon dilatationProcedure or surgery

    NC Balloon dilatation at pressure > NC-RBP (18-20 atm) with > 1 long inflation (> 20 minutes each)

  • Laser Excimer + NC BalloonProcedure or surgery

    Laser Excimer + NC Balloon dilatation at pressure > NC-RBP (18-20 atm) with > 1 long inflation (> 20 minutes each)

Study groups in NCT04359446
Study groupRoleWhat they receive
Stent under-expansion with NC BalloonOtherNot described
Receives: Procedure: NC ( Non- Compliant) Balloon dilatation
Stent under-expansion with Laser Excimer + NC BalloonOtherNot described
Receives: Procedure: Laser Excimer + NC Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Variation of the minimum luminal area (MLA)

    Detection of rate for Variation of the minimum luminal area (MLA) of the under-expanded stent defined as: ((MLAfinal-MLAinicial) / MLAinicial) x 100.

    Measured: During procedure

Secondary outcomes (8)

  1. Hyperacute thrombosis (THA)

    Detection of rate for Hyperacute thrombosis defined as: (number of THA patients cases detected / number of total patients cases) x 100.

    Measured: During procedure

  2. No- Reflow/Slow Flow (SFL)

    Detection of rate for no-reflow / slow flow rate (SFL), defined as (number of detected patients cases of SFL / number total cases) x 100.

    Measured: During procedure

  3. Bradycardia

    Detection of rate for Bradycardia (HR <50 beats / min or reduction of HR during application> 30%) defined as: (number of detected patients cases of bradycardia / number of total patients cases) x 100.

    Measured: During procedure

  4. Tachycardia

    Detection of rate for tachycardia, defined as: (ventricular or supraventricular tachycardias detected) during modification of the lesion, defined as (number of patients cases detected / number of total patients cases) x 100.

    Measured: During procedure

  5. Procedure time

    Determination of the duration time of the procedure in minutes

    Measured: During procedure

  6. Contrast Volume

    Determination of total contrast volume in mL

    Measured: During procedure

  7. Complications during procedure

    Detection of rate for complications, defined as: (number of patients cases of coronary perforation, occlusive dissection of the vessel, intra-procedure death, myocardial infarction / total number of cases) x 100.

    Measured: During procedure

  8. Periprocedural Infarction complications

    Detection of rate for periprocedural infarction complications, defined as: (number of patients cases of periprocedural infarction / total number of patients cases) x 100.

    Measured: During procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start12 Sep 2020
  3. Primary completion28 Jun 2023
  4. Study completion28 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04359446
Sponsor's protocol ID
EPIC16- LASER EXPAND
Acronym
LASER EXPAND
Status last verified
Aug 2023
First submitted
21 Apr 2020
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Byrne RA, Joner M, Kastrati A. Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Gruntzig Lecture ESC 2014. Eur Heart J. 2015 Dec 14;36(47):3320-31. doi: 10.1093/eurheartj/ehv511. Epub 2015 Sep 28.

    PubMed 26417060

  • Veerasamy M, Gamal AS, Jabbar A, Ahmed JM, Egred M. Excimer Laser With and Without Contrast for the Management of Under-Expanded Stents. J Invasive Cardiol. 2017 Nov;29(11):364-369.

    PubMed 29086727

  • Egred M. A novel approach for under-expanded stent: excimer laser in contrast medium. J Invasive Cardiol. 2012 Aug;24(8):E161-3.

    PubMed 22865316

  • Lam SC, Bertog S, Sievert H. Excimer laser in management of underexpansion of a newly deployed coronary stent. Catheter Cardiovasc Interv. 2014 Jan 1;83(1):E64-8. doi: 10.1002/ccd.25030. Epub 2013 Jul 1.

    PubMed 23703809

  • Egred M, Brilakis ES. Excimer Laser Coronary Angioplasty (ELCA): Fundamentals, Mechanism of Action, and Clinical Applications. J Invasive Cardiol. 2020 Feb;32(2):E27-E35. doi: 10.25270/jic/19.00325.

    PubMed 32005787

  • Latib A, Takagi K, Chizzola G, Tobis J, Ambrosini V, Niccoli G, Sardella G, DiSalvo ME, Armigliato P, Valgimigli M, Tarsia G, Gabrielli G, Lazar L, Maffeo D, Colombo A. Excimer Laser LEsion modification to expand non-dilatable stents: the ELLEMENT registry. Cardiovasc Revasc Med. 2014 Jan;15(1):8-12. doi: 10.1016/j.carrev.2013.10.005. Epub 2013 Oct 22.

    PubMed 24290659

  • Ben-Dor I, Maluenda G, Pichard AD, Satler LF, Gallino R, Lindsay J, Waksman R. The use of excimer laser for complex coronary artery lesions. Cardiovasc Revasc Med. 2011 Jan-Feb;12(1):69.e1-8. doi: 10.1016/j.carrev.2010.06.008. Epub 2010 Oct 20.

    PubMed 21241980

Questions about this trial

What is this clinical trial studying?

A study testing NC ( Non- Compliant) Balloon dilatation and Laser Excimer + NC Balloon in people with Cardiovascular Diseases and Arterial Disease, run by Fundación EPIC at 6 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation of the minimum luminal area (MLA) (time frame: During procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04359446, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.

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