Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention (PLAMI).
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DCB-PCI 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.
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.
Device: Angiography-derived coronary physiology (IMRangio)
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
|
Outcome Measures
Primary Outcome Measures
- 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
- Minimum lumen change [Baseline to 3 month follow-up.]
- Plaque burden change [Baseline to 3 month follow-up.]
- IMRangio change from baseline to post DCB-PCI [Baseline to post DCB-PCI]
- IMRangio change from post DCB-PCI to 3 month follow-up [Post DCB-PCI to 3 month follow-up]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patient with coronary artery disease undergoing percutaneous coronary intervention with DCB.
Exclusion Criteria:
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Aged < 18 years.
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Cardiogenic shock.
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ST-segment elevation myocardial infarction.
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Use of mechanical circulatory support.
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Chronic total occlusions, bifurcation lesions, left main coronary artery disease, severe calcified lesions, graft interventions and in-stent restenosis.
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Inability to provide informed consent.
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Unable to understand and follow study-related instructions or unable to comply with study protocol.
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Currently participating in another trial.
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Pregnant women.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario y Politécnico La Fe | Valencia | Spain | 46026 |
Sponsors and Collaborators
- Hospital Universitario La Fe
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.
- Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096.
- Sanz Sanchez J, Chiarito M, Cortese B, Moretti A, Pagnotta P, Reimers B, Stefanini GG, Ferrante G. Drug-Coated balloons vs drug-eluting stents for the treatment of small coronary artery disease: A meta-analysis of randomized trials. Catheter Cardiovasc Interv. 2021 Jul 1;98(1):66-75. doi: 10.1002/ccd.29111. Epub 2020 Jun 27.
- Stefanini GG, Alfonso F, Barbato E, Byrne RA, Capodanno D, Colleran R, Escaned J, Giacoppo D, Kunadian V, Lansky A, Mehilli J, Neumann FJ, Regazzoli D, Sanz-Sanchez J, Wijns W, Baumbach A. Management of myocardial revascularisation failure: an expert consensus document of the EAPCI. EuroIntervention. 2020 Dec 4;16(11):e875-e890. doi: 10.4244/EIJ-D-20-00487.
- Xu J, Lo S. Fundamentals and role of intravascular ultrasound in percutaneous coronary intervention. Cardiovasc Diagn Ther. 2020 Oct;10(5):1358-1370. doi: 10.21037/cdt.2020.01.15.
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