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Clinical Trial Summary

The objective of this randomized control trial is to gain clinical insight on the use of POT PTCA balloon dilatation catheter for the optimal dilation after drug-eluting stent implantation.

Clinical Trial Description

The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in minimal stent area (MLA) of POT PTCA balloon dilatation catheter on patients with drug-eluting stent (DES) implantation. Based on the previous studies, the MLA in the proximal and distal 3mm segments was 7.38 mm^2 and 8.08 mm^2 before non-compliant balloon (NCB) dilation, respectively. After NCB dilation, that MSA in the proximal and distal 3mm segments was 7.53mm^2 and 9.55mm^2, respectively. As a result, a total of 48 patients with DES implantation are randomized at a ratio of 1:1 to either POT PTCA balloon dilatation catheter group (POT group) or Quantum Maverick balloon catheter group (NCB group) using a randomization schedule blocked by site. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05368129
Study type Interventional
Source Nanjing First Hospital, Nanjing Medical University
Contact Shao-Liang Chen, MD, PhD
Phone +86-25-52271351
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date April 30, 2022
Completion date October 30, 2022

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