Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In patients with unprotected left main (LM) true bifurcation lesion (cohort A), elective 2-stent strategy is superior to provisional strategy at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.
In patients with unprotected LM non-true bifurcation lesion (cohort B), 1-stent technique with mandatory final kissing ballooning is superior to 1-stent technique without kissing ballooning at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One stent technique alone | Experimental | One stent technique alone for non-true LM bifurcation |
|
| One stent technique + Elective FKB | Experimental | One stent technique + Elective FKB for non-true LM bifurcation |
|
| Provisional approach | Experimental | Provisional approach for true LM bifurcation |
|
| Elective 2-stent | Experimental | Elective 2-stent for true LM bifurcation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One stent technique alone | Device | One stent technique alone with drug-eluting stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure | defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization | 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death | All deaths were considered cardiac unless a definite non-cardiac cause could be established. | 12-month |
| Angiographic in-segment restenosis rate | as measured by 9-month quantitative coronary analysis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hyeon-Cheol Gwon, MD,PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| One stent technique + Elective FKB | Device | One stent technique + Elective FKB with drug-eluting stents + balloon |
|
| Provisional approach | Procedure | Provisional approach with drung-eluting stents |
|
| Elective 2-stent | Device | Elective 2-stent with drug-eluting stents |
|
| 9 months |
| Target vessel revascularization (TVR) | TVR was defined as repeat revascularization of the target vessel by PCI or bypass graft surgery. | 12-month |
| Stent thrombosis | Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis. | 12-month |
| Myocardial infarction (MI) | MI was defined as elevated cardiac enzymes (troponin or MB fraction of creatine kinase, CK-MB) more than the upper limit of the normal value with ischemic symptoms or electrocardiography findings indicative of ischemia that was not related to the index procedure. | 12-month |
| Target lesion revascularization (TLR) | TLR was defined as repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel. | 12-month |
| Periprocedural CK-MB elevation | Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure. | the first 48 hours after PCI |
| Procedure success rate | the first 48 hours after PCI |
| Procedure time | immediate after PCI |
| Amount of contrast dye | immediate after PCI |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |