Clinical trial NCT03714802: Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases
Official title: Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases: SZABO Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: bifurcation lesion
percutaneous coronary intervention
Szabo
T-stenting
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patient must be at least ≥18 years of age.
* Lesions are eligible for percutaneous coronary intervention (PCI).
* Patient has stable/unstable angina or myocardial infarction (MI).
* Bifurcation lesions (Medina 1,1,1/0,1,1/1,0,1) without left main ostial lesions.
* Downstream lesions could be covered by two stents.
* Diameter of vessel ≥2.25mm
* Diameter stenosis in main vessel and side branch ≥ 50% by visual estimation.

Exclusion Criteria:

* Severe tortuosity or calcification affected procedural success.
* Patient was allergic to the study stent or protocol-required concomitant medications.
* Patient is intolerable to dual anti-platelet therapy.
* Patient has any other serious medical illness that may reduce life expectancy to\<12 months.
* Patient is a woman who is pregnant or nursing.
* Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
* Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.
* Coronary restenosis.

Primary outcomes:
measure: Composite of cardiac death, nonfatal myocardial infarction and target lesion revascularization
timeFrame: 1 year after coronary angiography
Secondary outcomes:
measure: rate of all cause death
timeFrame: 30 days and 12 months after primary angiography
measure: rate of cardiac death rate
timeFrame: 30 days and 12 months after primary angiography
measure: rate of recurrent myocardial infarction rate
timeFrame: 30 days and 12 months after primary angiography
measure: rate of target vessel revascularization rate
timeFrame: 30 days and 12 months after primary angiography
measure: rate of stent thrombosis
timeFrame: 30 days and 12 months after primary angiography
measure: residual stenosis degree
timeFrame: Immediately after stent implantation and 12 months after primary angiography
measure: residual stenosis of side branch
timeFrame: Immediately after stent implantation and 12 months after primary angiography
measure: late lumen loss
timeFrame: index procedure and 12 months follow up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
Study officials:
affiliation: Shanghai Zhongshan Hospital Fudan University
name: Junbo Ge, Professor
role: PRINCIPAL_INVESTIGATOR
References: