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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

stent technique: Provisional fKBT

stent technique: Routine fKBT

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

Edogawa Hospital
Saiseikai Yokohama City Eastern Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Provisional fKBT

Routine fKBT

Arm Description

Stent technique that final kissing balloon technique(fKBT) is performed if side branch flow was aggravated to TIMI0-2 after stent deployment

Stent technique that fKBT was mandatory irrespective of side branch flow after stenting.

Outcomes

Primary Outcome Measures

Rate of positive dipyridamole stress technetium scintigraphy

Secondary Outcome Measures

Composite of major cardiac adverse events(MACE)

Including cardiac death,myocardial infarction, stent thrombosis and target vessel revascularization

Angiographic restenosis rate in main vessel

Fluoroscopic time

Amount of contrast media

Number of stent and wire use

Diameter stenosis and late loss in side branch

Regional summed difference score

Full Information

NCT ID

NCT01238510

First Posted

November 9, 2010

Last Updated

April 22, 2013

Sponsor

Saiseikai Yokohama City Eastern Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01238510

Brief Title

Comparison Between Provisional Versus Routine Kissing Balloon Technique After Main Vessel Crossover Stenting for Bifurcated Lesions.

Acronym

PROTECT-SB

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Saiseikai Yokohama City Eastern Hospital

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Provisional fKBT

Arm Type

Active Comparator

Arm Description

Stent technique that final kissing balloon technique(fKBT) is performed if side branch flow was aggravated to TIMI0-2 after stent deployment

Arm Title

Routine fKBT

Arm Type

Active Comparator

Arm Description

Stent technique that fKBT was mandatory irrespective of side branch flow after stenting.

Intervention Type

Procedure

Intervention Name(s)

stent technique: Provisional fKBT

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

stent technique: Routine fKBT

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of positive dipyridamole stress technetium scintigraphy

Time Frame

7 month

Secondary Outcome Measure Information:

Title

Composite of major cardiac adverse events(MACE)

Description

Including cardiac death,myocardial infarction, stent thrombosis and target vessel revascularization

Time Frame

8 month

Title

Angiographic restenosis rate in main vessel

Time Frame

8 month

Title

Fluoroscopic time

Time Frame

after procedure

Title

Amount of contrast media

Time Frame

after procedure

Title

Number of stent and wire use

Time Frame

after procedure

Title

Diameter stenosis and late loss in side branch

Time Frame

8 month

Title

Regional summed difference score

Time Frame

7 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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,

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Masahiro Yamawaki, MD,PhD

Organizational Affiliation

Saiseikai Yokohama City Eastern Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Edogawa Hospital

City

Tokyo

Country

Japan

Facility Name

Saiseikai Yokohama City Eastern Hospital

City

Yokohama

ZIP/Postal Code

230-8765

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Comparison Between Provisional Versus Routine Kissing Balloon Technique After Main Vessel Crossover Stenting for Bifurcated Lesions.

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