NCT04984135

DCB Angioplasty for Coronary Lesions: an OCT Analysis

Drug-coated Balloon Angioplasty for De-novo or in-Stent Restenotic Coronary Lesions: an Optical Coherence Tomography Analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: The First Affiliated Hospital of Dalian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Coronary Stenosis
• Drug-coated Balloon

Interventions

Type	Name	Description
PROCEDURE	Percutaneous coronary intervention	All patients were treated with a loading dose of clopidogrel 300 or 600 mg before the procedure followed by maintenance clopidogrel 75 mg daily for 6 months. 100 U/ kg of unfractionated heparin was injected intravenously to maintain an activated clotting time ≥ 250 s during the procedure. For DCB treatment, the patient underwent predilation with an optimal-sized balloon (non-compliant balloon or cutting balloon) based on angiography (balloon-to-vessel ratio of 1.0), with the standard balloon shorter than the intended DCB size. The DCB was sized at 1:1 balloon-to-vessel ratio, delivered rapidly (median of 15 s) and inflated at nominal pressure for 60 s.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-07-01
• Completion: 2021-07-20
• First posted: 2021-07-30
• Last updated: 2021-08-16

Locations

1 site across 1 country: China