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

Sponsor
Fundación EPIC (Other)
Overall Status
Recruiting
CT.gov ID
NCT04359446
Collaborator
(none)
30
6
2
26.6
5
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: NC ( Non- Compliant) Balloon dilatation
  • Procedure: Laser Excimer + NC Balloon
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Laser-excimer Versus High-pressure Dilation to Treat Under-expansion of the Stent (LASER EXPAND Study)
Actual Study Start Date :
Sep 12, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Stent under-expansion with NC Balloon

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

Other: Stent under-expansion with Laser Excimer + NC Balloon

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

Outcome Measures

Primary Outcome Measures

  1. Variation of the minimum luminal area (MLA) [During procedure]

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

Secondary Outcome Measures

  1. Hyperacute thrombosis (THA) [During procedure]

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

  2. No- Reflow/Slow Flow (SFL) [During procedure]

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

  3. Bradycardia [During procedure]

    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.

  4. Tachycardia [During procedure]

    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.

  5. Procedure time [During procedure]

    Determination of the duration time of the procedure in minutes

  6. Contrast Volume [During procedure]

    Determination of total contrast volume in mL

  7. Complications during procedure [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.

  8. Periprocedural Infarction complications [During procedure]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
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.

Exclusion Criteria:
  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clinico Universitario de Santiago de Compostela Santiago De Compostela Coruña Spain 15706
2 Hospital Universitari Vall D'Hebron Barcelona Spain 08035
3 Hospital Universitario Reina Sofia Córdoba Spain 14004
4 Hospital Universitario Juan Ramon Jimenez Huelva Spain 21005
5 Hospital Universitario Lucus Agusti Lugo Spain 27003
6 Hospital Universitario La Paz Madrid Spain 28046

Sponsors and Collaborators

  • Fundación EPIC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fundación EPIC
ClinicalTrials.gov Identifier:
NCT04359446
Other Study ID Numbers:
  • EPIC16- LASER EXPAND
First Posted:
Apr 24, 2020
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundación EPIC
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022