Comparison Between Provisional Versus Routine Kissing Balloon Technique After Main Vessel Crossover Stenting for Bifurcated Lesions. (PROTECT-SB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masahiro Yamawaki, Saiseikai Yokohama City Eastern Hospital
ClinicalTrials.gov Identifier:
NCT01238510
First received: November 9, 2010
Last updated: April 22, 2013
Last verified: April 2013

November 9, 2010
April 22, 2013
March 2010
April 2013   (final data collection date for primary outcome measure)
Rate of positive dipyridamole stress technetium scintigraphy [ Time Frame: 7 month ] [ Designated as safety issue: Yes ]
Regional summed difference score [ Time Frame: 7 month ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01238510 on ClinicalTrials.gov Archive Site
  • Composite of major cardiac adverse events(MACE) [ Time Frame: 8 month ] [ Designated as safety issue: Yes ]
    Including cardiac death,myocardial infarction, stent thrombosis and target vessel revascularization
  • Angiographic restenosis rate in main vessel [ Time Frame: 8 month ] [ Designated as safety issue: No ]
  • Fluoroscopic time [ Time Frame: after procedure ] [ Designated as safety issue: No ]
  • Amount of contrast media [ Time Frame: after procedure ] [ Designated as safety issue: No ]
  • Number of stent and wire use [ Time Frame: after procedure ] [ Designated as safety issue: No ]
  • Diameter stenosis and late loss in side branch [ Time Frame: 8 month ] [ Designated as safety issue: No ]
  • Regional summed difference score [ Time Frame: 7 month ] [ Designated as safety issue: Yes ]
  • Composite of major cardiac adverse events(MACE) [ Time Frame: 8 month ] [ Designated as safety issue: Yes ]
    Including cardiac death,myocardial infarction, stent thrombosis and target vessel revascularization
  • Angiographic restenosis rate in main vessel [ Time Frame: 8 month ] [ Designated as safety issue: No ]
  • Fluoroscopic time [ Time Frame: after procedure ] [ Designated as safety issue: No ]
  • Amount of contrast media [ Time Frame: after procedure ] [ Designated as safety issue: No ]
  • Number of stent and wire use [ Time Frame: after procedure ] [ Designated as safety issue: No ]
  • Diameter stenosis and late loss in side branch [ Time Frame: 8 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison Between Provisional Versus Routine Kissing Balloon Technique After Main Vessel Crossover Stenting for Bifurcated Lesions.
Not Provided

In the setting of single stent strategy for treatment of bifurcation, we investigate to compare simple strategy as "provisional final kissing balloon technique(fKBT)" to complex one as "routine FKBT", focusing on actual myocardial ischemia assessed by scintigraphy in 7-month and to examine optimal endpoint of side branch ostium.

Final kissing balloon technique (FKBT) is effective and accepted technique for the treatment of bifurcation. However, in complex lesion or anatomy, much procedure-time and contrast media are needed to accomplish this technique. Recent FFR study for jailed side branch (SB) demonstrated that angiographic severe stenosis at SB ostium includes "pseudo-stenosis" and stent-deployment jailing SB without FKBT has comparable impact on clinical outcome with FKBT strategy. Considering simple technique for bifurcation, we sought to investigate to compare "provisional FKBT" with "routine FKBT", focusing on actual myocardial ischemia assessed by scintigraphy in 7 month and to examine optimal endpoint of SB ostium.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Procedure: stent technique: Provisional fKBT

    Provisional use of fKBT only when SB flow is aggravated to TIMI0-2 after stenting for non-left main bifurcation.

    Additional stenting for SB is recommended if residual stenosis (>50% in visual) or TIMI flow grade (<TIMI 3) was seen at SB after fKBT.

    Stent type: Everolimus-eluting stent only

  • Procedure: stent technique: Routine fKBT

    Mandatory use of fKBT irrespective of SB flow after stenting for non-left main bifurcation. Additional stenting for SB is recommended if residual stenosis (>50% in visual) or TIMI flow grade (<TIMI 3) was seen at SB after fKBT.

    Stent type: Everolimus-eluting stent only

  • Active Comparator: Provisional fKBT
    Stent technique that final kissing balloon technique(fKBT) is performed if side branch flow was aggravated to TIMI0-2 after stent deployment
    Intervention: Procedure: stent technique: Provisional fKBT
  • Active Comparator: Routine fKBT
    Stent technique that fKBT was mandatory irrespective of side branch flow after stenting.
    Intervention: Procedure: stent technique: Routine fKBT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

(Patient) Patient who has angina or documented ischemia, Patients who are eligible for drug eluting stent, Age >=18, Patient who received informed consent, Patient who can receive dipyridamole-stress-technetium scintigraphy.

(Lesion) Non-left main bifurcation except for Medina class (0,0,1), De-Novo lesion, Vessel diameter in visual (main vessel>2.5mm, side branch >2.0mm), SB lesion length <5mm in visual estimate, MB lesion length < 46mm in visual, TIMI 3 in main vessel as well as side branch,

Exclusion Criteria:

(Patient) Patients who is pregnant, Patient contraindicated for antiplatelet therapy, Patients whose ejection fraction is less than 30%, Patients who has renal dysfunction, creatinine >=2.3, Patients who has live dysfunction, Patients who cannot agree with informed consent, Patient whose life expectancy is less than 1 year, Patients contraindicated for dipyridamole-stress-technetium scintigraphy.

(Lesion) Target site of acute myocardial infarction, Left main disease, In-Stent restenosis lesion, Bypass graft, Chronic total occlusion, Main vessel reference diameter >4.5mm, Bifurcation lesion that needs intended 2 stent strategy, Highly tortus and calcified lesion,

Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01238510
2009009
Not Provided
Masahiro Yamawaki, Saiseikai Yokohama City Eastern Hospital
Saiseikai Yokohama City Eastern Hospital
Not Provided
Principal Investigator: Masahiro Yamawaki, MD,PhD Saiseikai Yokohama City Eastern Hospital
Saiseikai Yokohama City Eastern Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP