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

NCT04359446 | Completed DMC

• 1 other identifier: EPIC16- LASER EXPAND
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 6

Brief 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 dilatation at high or very high pressure.

Conditions

Cardiovascular Diseases; Arterial Disease

Keywords

LASER EXPAND

Outcome Measures

Primary Outcomes (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.

  During procedure

Secondary Outcomes (8)

• Hyperacute thrombosis (THA)

  During procedure

• No- Reflow/Slow Flow (SFL)

  During procedure

• Bradycardia

  During procedure

• Tachycardia

  During procedure

• Procedure time

  During procedure

Study Arms (2)

Stent under-expansion with NC Balloon

OTHER

Procedure: NC ( Non- Compliant) Balloon dilatation

Stent under-expansion with Laser Excimer + NC Balloon

OTHER

Procedure: Laser Excimer + NC Balloon

Interventions

NC ( Non- Compliant) Balloon dilatation PROCEDURE

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

Stent under-expansion with NC Balloon

Laser Excimer + NC Balloon PROCEDURE

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

Stent under-expansion with Laser Excimer + NC Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (6)

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Coruña, 15706, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario Juan Ramon Jimenez

Huelva, 21005, Spain

Location

Hospital Universitario Lucus Agusti

Lugo, 27003, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (7)

• 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.

  PMID: 26417060 BACKGROUND

• 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.

  PMID: 29086727 BACKGROUND

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

  PMID: 22865316 BACKGROUND

• 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.

  PMID: 23703809 BACKGROUND

• 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.

  PMID: 32005787 BACKGROUND

• 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.

  PMID: 24290659 BACKGROUND

• 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.

  PMID: 21241980 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Lasers, Excimer

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: September 12, 2020
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

ES (6)