研究目的
To investigate whether the expansion index after implantation of DREAMS 2G as assessed by optical coherence tomography (OCT) impacts late luminal status and healing of the vessel wall.
研究成果
Excellent healing was observed with DREAMS 2G, but higher expansion indices were associated with greater luminal volume loss, suggesting that excessive expansion should be avoided to reduce in-scaffold LVL.
研究不足
Small sample size, short 6-month follow-up period, exclusion of complex lesions and STEMI patients, lack of pre-implantation OCT, and non-randomized design.
1:Experimental Design and Method Selection:
Prospective, multi-center study using OCT to assess scaffold expansion and healing.
2:Sample Selection and Data Sources:
65 patients from the BIOSOLVE-II trial with de novo coronary artery lesions, selected based on inclusion/exclusion criteria.
3:List of Experimental Equipment and Materials:
DREAMS 2G scaffold, OCT system (ILUMIEN by St Jude Medical), offline analysis software (QIVUS by MEDIS).
4:Experimental Procedures and Operational Workflow:
OCT imaging performed post-procedure and at 6-month follow-up, with frame-by-frame analysis of expansion index and qualitative findings.
5:Data Analysis Methods:
Statistical analysis using JMP Pro software, including t-tests, Mann-Whitney U tests, and Spearman correlation.
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