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

NCT04359446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-08-08

No results posted yet for this study

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

Interventions

PROCEDURE

NC ( Non- Compliant) Balloon dilatation

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

PROCEDURE

Laser Excimer + NC Balloon

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

Sponsors & Collaborators

  • Fundación EPIC

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-12
Primary Completion
2023-06-28
Completion
2023-06-28

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04359446 on ClinicalTrials.gov