Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention (PLAMI).

La Fe University and Polytechnic Hospital

Status: Enrolling

Conditions: Plaque Modification; Coronary Artery Disease; Percutaneous Coronary Intervention; Intravascular Ultrasound; Microvascular Coronary Artery Disease; Drug Coated-balloon

Treatments: Device: Drug coated-balloon percutaneous coronary intervention.; Device: Angiography-derived coronary physiology (IMRangio)

Study type: Interventional

Funder types: Other

Identifiers

NCT06080919

523

Details and patient eligibility

About

Coronary artery disease (CAD) is one of the most common causes of mortality worldwide. Despite drug eluting stents (DES) are the most common treatment strategy, drug-coated balloons (DCB) represent an appealing alternative to DES as they eliminate the risk of stent thrombosis and do not leave any type of metallic structure in the vessel wall. However, the evidence of the vessel wall healing processes, plaque remodeling, plaque composition and impact on coronary microcirculation after PCI with DCB have not yet been characterized.

The purpose of this study is to assess the changes in percentage atheroma volume evaluated by intravascular ultrasound (IVUS) in patients undergoing DCB-PCI.

Full description

The study will be an investigator-initiated, single-arm, open-label, pilot study in patients undergoing PCI with DCB for the novo lesion.

Because of the exploratory nature of this study, no formal sample size calculation is required. On the basis of previous pilot studies with similar designs, a sample of 30 lesions is planned to be evaluated.

After being informed about the study and the potential risks, all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent. Patients will go DCB-PCI. IVUS will be evaluated prior to PCI-DCB, immediately after and at 3-month follow-up. Angiography-derived coronary physiology will be assessed after the procedure using Angio Plus software (Pulse Medical Imaging Technology, Shanghai, China). The angiography images will be used to obtain the IMRangio values, prior, post to DCB-PCI and 3 month follow-up.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with coronary artery disease undergoing percutaneous coronary intervention with DCB.

Exclusion criteria

• Aged < 18 years.
• Cardiogenic shock.
• ST-segment elevation myocardial infarction.
• Use of mechanical circulatory support.
• Chronic total occlusions, bifurcation lesions, left main coronary artery disease, severe calcified lesions, graft interventions and in-stent restenosis.
• Inability to provide informed consent.
• Unable to understand and follow study-related instructions or unable to comply with study protocol.
• Currently participating in another trial.
• Pregnant women.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

DCB-PCI

Experimental group

Description:

Patients with coronary artery disease undergoing percutaneous coronary intervention will undergo DCB-PCI under IVUS guidance and angio-derived coronary phisiology assessment. Angiographic follow-up with IVUS evaluation will be performed 3 months after the index procedure.

Treatment:

Device: Drug coated-balloon percutaneous coronary intervention.

Device: Angiography-derived coronary physiology (IMRangio)