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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention.

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

Intervention / Treatment
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* Device: Drug coated-balloon percutaneous coronary intervention.
* Device: Angiography-derived coronary physiology (IMRangio)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study will be an investigator-initiated, single-arm, open-label, pilot study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCB-PCI<br>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. | Device: Drug coated-balloon percutaneous coronary intervention.<br>* Patients will undergo DCB-PCI under IVUS guidance (OpticrossTMHD 60 MHz). Target lesion will be predilated with semi-compliant balloons or non-compliant balloons.The lesion will be then treated with DCB with a reference vessel diameter/balloon diameter ratio of 1.<br>Device: Angiography-derived coronary physiology (IMRangio)<br>* 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 and post to DCB-PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of minimum lumen change baseline to 3 month follow-up. |  | Baseline to 3 month follow-up. | 
| Percentage of plaque burden 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 |