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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Procedure: stent technique: Provisional fKBT
Procedure: stent technique: Routine fKBT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Saiseikai Yokohama City Eastern Hospital:

Primary Outcome Measures:
  • Rate of positive dipyridamole stress technetium scintigraphy [ Time Frame: 7 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 120
Study Start Date: March 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Active Comparator: Routine fKBT
Stent technique that fKBT was mandatory irrespective of side branch flow after stenting.
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


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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,

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01238510

Locations
Japan
Edogawa Hospital
Tokyo, Japan
Saiseikai Yokohama City Eastern Hospital
Yokohama, Japan, 230-8765
Sponsors and Collaborators
Saiseikai Yokohama City Eastern Hospital
Investigators
Principal Investigator: Masahiro Yamawaki, MD,PhD Saiseikai Yokohama City Eastern Hospital
  More Information

No publications provided

Responsible Party: Masahiro Yamawaki, Cardiology, Saiseikai Yokohama City Eastern Hospital
ClinicalTrials.gov Identifier: NCT01238510     History of Changes
Other Study ID Numbers: 2009009
Study First Received: November 9, 2010
Last Updated: April 22, 2013
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014