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Coronary Artery DiseasePhase 4PROTECT-SBNCT01238510

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

A Phase 4 study testing stent technique: Provisional fKBT and stent technique: Routine fKBT in people with Coronary Artery Disease, run by Saiseikai Yokohama City Eastern Hospital at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
stent technique: Provisional fKBT and stent technique: Routine fKBT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesJapan
Study dates
Mar 2010to Apr 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (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,

Who cannot join

  • (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,

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Edogawa Hospital

    Tokyo

  • Saiseikai Yokohama City Eastern Hospital

    Yokohama, 230-8765

Other trials in Japan

About this study

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.

Read the 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.

Being tested
stent technique: Provisional fKBT, stent technique: Routine fKBT
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stent technique: Provisional fKBTProcedure or surgery

    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

  • stent technique: Routine fKBTProcedure or surgery

    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

Study groups in NCT01238510
Study groupRoleWhat they receive
Provisional fKBTActive comparatorStent technique that final kissing balloon technique(fKBT) is performed if side branch flow was aggravated to TIMI0-2 after stent deployment
Receives: Procedure: stent technique: Provisional fKBT
Routine fKBTActive comparatorStent technique that fKBT was mandatory irrespective of side branch flow after stenting.
Receives: Procedure: stent technique: Routine fKBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of positive dipyridamole stress technetium scintigraphy

    Measured: 7 month

Secondary outcomes (7)

  1. Composite of major cardiac adverse events(MACE)

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

    Measured: 8 month

  2. Angiographic restenosis rate in main vessel

    Measured: 8 month

  3. Fluoroscopic time

    Measured: after procedure

  4. Amount of contrast media

    Measured: after procedure

  5. Number of stent and wire use

    Measured: after procedure

  6. Diameter stenosis and late loss in side branch

    Measured: 8 month

  7. Regional summed difference score

    Measured: 7 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01238510
Sponsor's protocol ID
2009009
Acronym
PROTECT-SB
Status last verified
Apr 2013
First submitted
9 Nov 2010
Last updated
23 Apr 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing stent technique: Provisional fKBT and stent technique: Routine fKBT in people with Coronary Artery Disease, run by Saiseikai Yokohama City Eastern Hospital at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of positive dipyridamole stress technetium scintigraphy (time frame: 7 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01238510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.

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