Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques (MV:main branch)
Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis. Their structural properties make angioplasty technique to increase the difficulty of implementation, but also increased the risks of the in-stent thrombosis and restenosis. Standard treatment of coronary bifurcation lesions remains controversial manner, especially when the side branch (SB) was large combined with high angulated bifurcation lesions. Complex procedures and certain types of lesions are associated with poor prognosis. There is no standard treatment for such lesions even with the development of drug-eluting stents solve partial problems. The investigators reviewed patients who received coronary intervention between 2009-2012 years and met the inclusion criteria, and then analyzed the prognostic relevance of these cases the use of different treatment modalities.
We introduced a retrospective analysis for high angulated bifurcation lesions treated with either DES or BMS.
Primary endpoint: cardiovascular mortality, TLR, MACE. secondary endpoint: procedure time, fluoroscopy time, procedure success, angiographic success.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Taipei, Taiwan, 52005
- Taipei City Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Angulated bifurcation:MV(main branch) and SB(side branch) angle>70 degree. MV diameter≥2.5mm and eligible for stenting. lesion stenotic severity>70% by QCA(Quantitative coronary analysis). 1 stent strategy. SYNTAX>22 Procedure success. de novo lesion
Exclusion Criteria:
- Bifurcation lesions intervention without side br. ballooning after stents deployment or procedure incomplete. Left main coronary artery bifurcational lesions. Elective,provisional or bail-out stenting for side br.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
sequential ballooning
include BMS or DES
|
|
final kissing ballooning
include BMS or DES
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With Major Adverse Cardiac Events(MACE)
Tidsramme: periprocedure up to 12 months
|
Percentage of Participants with major adverse cardiac events(MACE) was defined as rates of target lesion revascularization (TLR) and restenosis during first post-treatment year, and rates of acute, subacute, and late in-stent thrombosis, periprocedure MI(myocardial infarction).
|
periprocedure up to 12 months
|
|
Percentage of Participants With Cardiovascular Mortality(%)
Tidsramme: periprocedure up to 12 months
|
Percentage of Participants with cardiovascular mortality was defined as death related to cardiovascular causes within 2 years.
|
periprocedure up to 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With Angiographic Success(%)
Tidsramme: periprocedure up to 12 months.
|
Percentage of Participants with angiographic success was defined as residual stenosis<50% under fluoroscopy at the end of procedure.
|
periprocedure up to 12 months.
|
|
Percentage of Participants With Target Vessel Revascularization Rate
Tidsramme: periprocedure up to 12 months.
|
Percentage of Participants with target vessel revascularization rate, both arms
|
periprocedure up to 12 months.
|
|
Fluoroscopy Time(Minutes) of Each Participants
Tidsramme: periprocedure up to 12 months.
|
as medical chart record.
|
periprocedure up to 12 months.
|
|
Procedure Time(Minutes) of Each Participants
Tidsramme: periprocedure up to 12 months.
|
as medical chart record.
|
periprocedure up to 12 months.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TCHIRB-1030209-E
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