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

Fundación EPIC

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent; Device: Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT06657833

EPIC40-DEBSCAN-IVL

Details and patient eligibility

About

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).

Full description

Regardless some observational data of DEB performance in calcified lesions, there is a lack of data about the safety and efficacy in the setting of calcified nodules. However, a "leave-nothing-behind" PCI strategy is attractive in this scenario in which the probability of non-optimal stent expansion and apposition is higher, hypothesis is, that following optimal plaque modification with IVL, the utilization of a DEB is either non-inferior or possibly superior to DES in terms of late lumen loss and net luminal gain at 6 months follow up.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients must meet all inclusion criteria:

• Patients >18 years admitted for stable coronary artery disease or acute coronary syndromes and indication for percutaneous coronary intervention (PCI) and
• Severe coronary lesion with a calcified nodule (highly recommended confirmation with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and
• Lesion to treat in a vessel between 2.5 and 4 mm

Exclusion criteria

Patients must not meet any criteria

• Inability to provide oral and written informed consent or unwillingness to come back for systematic angiographic follow-up.
• Pregnant patients
• Cardiogenic Shock or Cardiac arrest at the moment of the index procedure.
• Impossibility to maintain double antiplatelet treatment during at least 1 month.
• Life expectancy <1 year.
• Index lesion at left main stem.
• Aorto-ostial lesion.
• Target lesion previously treated with stents or DEB.
• High thrombus burden in the target lesion (TIMI thrombus scale≥3).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

128 participants in 2 patient groups

Drug Eluting Balloon (DEB)

Other group

Treatment:

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

Drug Eluting Stent (DES)

Other group

Treatment:

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