Viewing Study NCT03714802


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Study NCT ID: NCT03714802
Status: UNKNOWN
Last Update Posted: 2019-03-05
First Post: 2018-09-21
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases
Sponsor: Shanghai Zhongshan Hospital
Organization:

Study Overview

Official Title: Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases: SZABO Trial
Status: UNKNOWN
Status Verified Date: 2018-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The study will compare clinical outcomes of modified T-stenting with Szabo technique with T-stenting for bifurcation lesions in coronary heart diseases.
Detailed Description: Accurate deployment of stents in ostial lesions is difficult with traditional angiographic guidance. Szabo technique, which used a second angioplasty guide wire to anchor the stent by passing the proximal end of the anchor wire through the last cell of the stent, demonstrated accurate placement of the stents in ostial locations. In bifurcation lesions, 2-stent strategy positioning with Szabo technique was not investigated. Modified T-stenting with Szabo technique may improve prognosis of bifurcation lesions through reducing stents overlap. There is no clinical trial focuses on the effect and outcome of Szabo technique for coronary artery bifurcation lesions in contrast with conventional strategy.

In this study, the authors choose the closest 2-stent strategy, T-stenting, as control. We hope to determine whether a planned Szabo 2-stent technique is superior to T-stenting for patients with bifurcation lesions.

Patients with bifurcation lesions will be randomly assigned to receive Szabo 2-stent technique or T-stenting strategy. Clinical outcomes and imaging assessment will be used to estimate their effects.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: