Coronary Artery Disease
Conditions
Keywords
bifurcation lesion, percutaneous coronary intervention, Szabo, T-stenting
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.
Interventions
PROCEDURESzabo T-Stenting Technique
2-stent strategy was performed using modified T-stenting with Szabo technique in bifurcation lesions. First, stent was implanted in the side branch with Szabo technique. Then, stent was implanted in the main branch. Finally, kissing balloon inflation was performed.
PROCEDURET-Stenting Technique
2-stent strategy was performed using traditional T-stenting technique in bifurcation lesions. First, stent was implanted in the side branch with angiographic guidance. Then, stent was implanted in the main branch. Finally, kissing balloon inflation was performed.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of cardiac death, nonfatal myocardial infarction and target lesion revascularization | 1 year after coronary angiography | record in follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of cardiac death rate | 30 days and 12 months after primary angiography | Recorded in follow-up |
| rate of recurrent myocardial infarction rate | 30 days and 12 months after primary angiography | Recorded in follow-up |
| rate of target vessel revascularization rate | 30 days and 12 months after primary angiography | Recorded in follow-up |
| rate of all cause death | 30 days and 12 months after primary angiography | Recorded in follow-up |
| residual stenosis degree | Immediately after stent implantation and 12 months after primary angiography | Measured through intravenous ultrasound |
| residual stenosis of side branch | Immediately after stent implantation and 12 months after primary angiography | Measured through angiography |
| late lumen loss | index procedure and 12 months follow up | Measured through intravenous ultrasound |
| rate of stent thrombosis | 30 days and 12 months after primary angiography | Recorded in follow-up |
Countries
China
Contacts
Primary ContactHongbo Yang, M.D.
Backup ContactZheyong Huang, M.D.
Outcome results
None listed