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Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Implantation — POT-DES  

Coronary Artery Disease Clinical Trial

Official title:
Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After Drug-eluting Stent Implantation: a Prospective, Multicenter, Randomized Controlled Clinical Trial

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

Clinical Trial Details
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
View Details
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