DCB Angioplasty for Coronary Lesions: an OCT Analysis

Completed

• Conditions: Coronary Stenosis; Drug-coated Balloon
• Interventions: Procedure: Percutaneous coronary intervention

• Registration Number: NCT04984135
• Lead Sponsor: The First Affiliated Hospital of Dalian Medical University

Brief Summary

In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization. The aim of this study was to investigate the relationship between quantitative and qualitative OCT findings, angiographic and clinical outcomes after PCB for coronary lesions.

Detailed Description

The paclitaxel drug-coated balloon (DCB) is an emerging device in percutaneous coronary intervention (PCI); it allows a rapid local release of an anti-restenotic drug without the use of a durable polymer or metal scaffold. The DCB has been proven to be effective with paclitaxel in preclinical trials and in clinical practice for the treatment of coronary lesions such as in-stent restenosis (ISR), de novo and bifurcation lesions. Optical coherence tomography (OCT) is an intravascular imaging modality that has higher resolution than intravascular ultrasound. Excellent contrast among lumen, vessel, and stent in OCT images allows accurate measurement of lumen and lesion. However, only a few studies have investigated the effect of DCB on the intimal lumen in the acute phase and during the follow-up using optical coherence tomography (OCT). In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization.

Demographic, angiographic, and procedural data were collected. Participants were followed up with coronary angiography and OCT for at least 6-9 months, combined with OCT to analyze qualitative analysis of changes in plaque characterization, and late lumen loss. The participants were followed up for long-term clinical events (including cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization).

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-20
• Study First Submitted: 2021-07-25
• Study First Submitted QC: 2021-07-25
• Study First Posted: 2021-07-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Coronary angiography shows that at least one coronary artery has a diameter stenosis >70% (left main stem diameter stenosis>50%)
• Stable or unstable angina
• Availability for follow-up for up to 12 months

Exclusion Criteria

• Acute myocardial infarction within 48 hours
• Severe calcified lesions
• Unable to tolerate dual antiplatelet treatment (DAPT)
• Severe abnormal hematopoietic system, such as platelet count of < 100×109/L or > 700×109/L and white blood cell count of < 3×109/L
• Active bleeding or bleeding tendency
• Severe coexisting conditions, such as severe renal insufficiency (GFR < 60 ml/min•1.73m2), severe hepatic dysfunction [elevated ALT (glutamicpyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
• Life expectancy < 12 months
• Pregnancy or planning pregnancy
• Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc.
• Participation or planning to participate in another clinical trial during the same period
• Refusal to comply with the study protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enrolled patients	Percutaneous coronary intervention	Patients fulfilling the study criteria were included.

Primary Outcome Measures

Name	Time	Method
In-segment late lumen loss	6 months	Changes to lumen area assessed with the use of OCT

Secondary Outcome Measures

Name	Time	Method
Target lesion failure	6 months	The secondary endpoint was the incidence of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR) at 6 months.

Trial Locations

Locations (1)

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China