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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Drug Coated-balloon; Percutaneous Coronary Intervention; Plaque Modification; Intravascular Ultrasound; Microvascular Coronary Artery Disease
• Interventions: Device: Drug coated-balloon percutaneous coronary intervention.; Device: Angiography-derived coronary physiology (IMRangio)

• Registration Number: NCT06080919
• Lead Sponsor: Hospital Universitario La Fe

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-09-12
• Study First Submitted: 2022-09-22
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-08
• Study First Posted: 2023-10-12
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-02
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCB-PCI	Drug coated-balloon percutaneous coronary intervention.	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.
DCB-PCI	Angiography-derived coronary physiology (IMRangio)	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.

Primary Outcome Measures

Name	Time	Method
Change in percentage atheroma volume evaluated by intravascular ultrasound (IVUS) from baseline at 3 month follow-up.	Baseline to 3 month follow-up.

Secondary Outcome Measures

Name	Time	Method
Percentage of plaque burden change baseline to 3 month follow-up.	Baseline to 3 month follow-up.
Percentage of minimum lumen change baseline to 3 month follow-up.	Baseline to 3 month follow-up.
Rate of IMRangio change from baseline to post DCB-PCI	Baseline to post DCB-PCI
Rate of IMRangio change from post DCB-PCI to 3 month follow-up	Post DCB-PCI to 3 month follow-up

Trial Locations

Locations (1)

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain