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DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.

NCT06657833 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-02-12

No results posted yet for this study

Summary

International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting stents (DES).

Conditions

Interventions

DEVICE

Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon

Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon

DEVICE

Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent

Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent

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
2024-12-17
Primary Completion
2027-10-30
Completion
2027-10-30

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 NCT06657833 on ClinicalTrials.gov