Coronary Artery DiseaseJBTinCBLNCT02167230
Jailed-balloon Technique in Coronary Bifurcation Lesion PCI
A study testing Jailed-balloon technique and Jailed-wire technique in people with Coronary Artery Disease, run by Guangdong Provincial People's Hospital at 2 sites in China.
Trial summary
This study aims to test the hypothesis that jailed-balloon technique(JBT) is superior to jailed-wire technique(JWT) in non-left main coronary bifurcation percutaneous coronary intervention(PCI) by lowering the risk of side branch(SB) loss and PCI related myocardial infarction, as well as 1-year major adverse… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Jailed-balloon technique and Jailed-wire technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2014to Sep 2017
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤75 years;
- De novo Medina 1,1,1 coronary bifurcation with a main branch(MB) >2.5mm while side branch <2.5mm and >1.5mm;
- Only one bifurcation lesion need to be treated in one vessel;
- The target lesion in MB has stenosis more than 75% or fractional flow reserve(FFR) less than 0.75 and the stenosis in SB ostium is more than 50%;
- Signed consent is obtained.
Who cannot join
- Left ventricular ejection fraction(LVEF) less than 30%;
- Hemodynamic instability or cardiac shock;
- Myopathy or muscular injury with elevation of creatine kinase to more than 3mg/dL;
- Tumor with expected survival less than 1 year;
- Autoimmune disease;
- Active gastrointestinal bleeding or any contraindication for dual antiplatelet therapy;
Show all 13Show fewer
- Acute coronary syndrome require emergency PCI;
- Coronary bifurcation need to be treated with two-stent strategy;
- Not suitable for drug-eluting stent(DES) implantation;
- Mental disorder or alcohol dependence;
- PCI or coronary artery bypass graft (CABG) within 6 months before enrollment;
- Target lesion is in-stent restenosis;
- Women in gestation period or lactation period or human chorionic gonadotropin (HCG) urine test positive.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Kashgar District 1st People's Hospital
Kashgar, Xinjiang, 844000
Heyin Yang, Bachelor, 86-998-2565206, 13579068456@163.com
Yuying Hu, Bachelor, 86-998-2565208, huyuyingks@163.com
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Shaohong Dong, Doctor, 86-755-25533018 ext. 3221, dsh266@medmail.com
Huadong Liu, Doctor, 86-755-25533018 ext. 3202, lhd2578@163.com
About this study
Official title: Effect of Jailed-Balloon Technique in Percutaneous Coronary Intervention for Non-Left Main Coronary Bifurcation Lesions: A Prospective, Randomized Study.
This study aims to test the hypothesis that jailed-balloon technique(JBT) is superior to jailed-wire technique(JWT) in non-left main coronary bifurcation percutaneous coronary intervention(PCI) by lowering the risk of side branch(SB) loss and PCI related myocardial infarction, as well as 1-year major adverse cardiovascular events(MACEs).
Read the detailed description
- Objective: To compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
- Background: Solid evidence is scant to compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
- Study design: This is a multi-center, prospective, randomized study.
- Methods
4a. Study populations: Patients with non-left main coronary bifurcation lesions(Medina 1,1,1 ), which SBs are less than 2.5mm and more than 1mm, are enrolled in this study. Patients are randomized to JBT group and JWT group.
4b. Procedure: For patients enrolled in JBT group, a monorail balloon is placed at the ostium of SB to protect the SB before the stent in main branch(MB) is deployed. Only a PTCA wire would be placed in the SB while stenting MB for patients randomized in JWT group. Only drug-eluting stent should be implanted in the target vessel.
- Conditions
- Coronary Artery Disease
- Being tested
- Jailed-balloon technique, Jailed-wire technique
- Keywords
- Coronary Artery Disease, Percutaneous Coronary Intervention, Bifurcation, Jailed-balloon technique
- 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.
Jailed-balloon techniqueProcedure or surgery
A monorail balloon is placed in the side branch(SB) before the stent in main branch(MB) is deployed. After MB stent is deployed to nominal pressure, the balloon in SB is inflated to 3 atm generally but to higher pressure to perform angioplasty if the blood flow in SB is compromised. The balloon in SB is then removed while the wire in SB is left in place. The MB stent balloon is inflated again for stent apposition. The SB wire is left in place to facilitate rewiring if the blood flow in SB is compromised. Otherwise the SB wire is removed after the stent balloon is inflated again.
Jailed-wire techniqueProcedure or surgery
A percutaneous transluminal coronary angioplasty(PTCA) wire is placed in the side branch(SB) before the stent in main branch(MB) is deployed. After MB stent is deployed to some pressure to achieve full apposition, the wire in SB is left in place to facilitate rewiring if the blood flow in SB is compromised. Otherwise the SB wire is removed after the MB stent is deployed.
| Study group | Role | What they receive |
|---|---|---|
| Jailed-balloon technique | Experimental | Apply jailed-balloon technique to protect the side branch during coronary bifurcation PCI Receives: Procedure: Jailed-balloon technique |
| Jailed-wire technique | Active comparator | Apply jailed-wire technique to protect the side branch during coronary bifurcation PCI Receives: Procedure: Jailed-wire technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side branch(SB) loss and PCI related myocardial infarction
The primary outcome of the study is a composite of SB loss or PCI related myocardial infarction.
According to Thrombolysis in Myocardial Infarction (TIMI) flow grading system, SB loss is defined as less than TIMI 3 flow immediately following MB stenting. It is considered temporary SB loss if TIMI 3 flow is restored with angioplasty and/or stenting. Otherwise, SB loss is considered permanent.
In patients with normal (≤99th percentile URL) baseline cardiac troponin(cTn) concentrations, PCI related myocardial infarction is defined as elevations of cTn >5× 99th percentile URL occurring within 48 hours of the procedure, which should be accompanied with other evidence of myocardial injury. A rise of >20% is required for the diagnosis of PCI related myocardial infarction if the baseline cTn values are elevated and are stable or falling.
Measured: Within 48 hours after PCI
Secondary outcomes (2)
Major adverse cardiovascular events(MACEs)
MACEs is a composite end point including cardiac death, non fatal myocardial infarction and target vessel revascularization(TVR).
Measured: Within 1 year after PCI
PCI related complication
PCI related complication include coronary dissection, coronary perforation, device dislodgement, device entrapment and device rupture.
Measured: Immediately after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen People's Hospital, Kashgar 1st People's Hospital
- Responsible party
- Sponsor
- Investigators
- Jiyan Chen, Doctor, Study chair, Guangdong Provincial People's HospitalJianfang Luo, Doctor, Study director, Guangdong Provincial People's HospitalPengcheng He, Doctor, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167230
- Sponsor's protocol ID
- JBT
- Acronym
- JBTinCBL
- Status last verified
- Jun 2014
- First submitted
- 17 Jun 2014
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sharma SK, Sweeny J, Kini AS. Coronary bifurcation lesions: a current update. Cardiol Clin. 2010 Feb;28(1):55-70. doi: 10.1016/j.ccl.2009.10.001.
PubMed 19962049Latib A, Colombo A. Bifurcation disease: what do we know, what should we do? JACC Cardiovasc Interv. 2008 Jun;1(3):218-26. doi: 10.1016/j.jcin.2007.12.008.
PubMed 19463303Depta JP, Patel Y, Patel JS, Novak E, Yeung M, Zajarias A, Kurz HI, Lasala JM, Bach RG, Singh J. Long-term clinical outcomes with the use of a modified provisional jailed-balloon stenting technique for the treatment of nonleft main coronary bifurcation lesions. Catheter Cardiovasc Interv. 2013 Nov 1;82(5):E637-46. doi: 10.1002/ccd.24778. Epub 2013 Jul 30.
PubMed 23420654Colombo F, Biondi-Zoccai G, Infantino V, Omede P, Moretti C, Sciuto F, Siliquini R, Chiado S, Trevi GP, Sheiban I. A long-term comparison of drug-eluting versus bare metal stents for the percutaneous treatment of coronary bifurcation lesions. Acta Cardiol. 2009 Oct;64(5):583-8. doi: 10.2143/AC.64.5.2042686.
PubMed 20058502Singh J, Patel Y, Depta JP, Mathews SJ, Cyrus T, Zajarias A, Kurz HI, Lasala JM, Bach RG. A modified provisional stenting approach to coronary bifurcation lesions: clinical application of the "jailed-balloon technique". J Interv Cardiol. 2012 Jun;25(3):289-96. doi: 10.1111/j.1540-8183.2011.00716.x. Epub 2012 Feb 26.
PubMed 22364484
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Jailed-Balloon Technique in Percutaneous Coronary Intervention for Non-Left Main Coronary Bifurcation Lesions: A Prospective, Randomized Study.
- ClinicalTrials.gov ID
- NCT02167230
- Acronym / sponsor ID
- JBTinCBL / JBT
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Percutaneous Coronary Intervention, Bifurcation, Jailed-balloon technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Shenzhen People's Hospital, Kashgar 1st People's Hospital
- Study start
- Oct 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to test the hypothesis that jailed-balloon technique(JBT) is superior to jailed-wire technique(JWT) in non-left main coronary bifurcation percutaneous coronary intervention(PCI) by lowering the risk of side branch(SB) loss and PCI related myocardial infarction, as well as 1-year major adverse cardiovascular events(MACEs).
Detailed description
- Objective: To compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
- Background: Solid evidence is scant to compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
- Study design: This is a multi-center, prospective, randomized study.
- Methods
4a. Study populations: Patients with non-left main coronary bifurcation lesions(Medina 1,1,1 ), which SBs are less than 2.5mm and more than 1mm, are enrolled in this study. Patients are randomized to JBT group and JWT group.
4b. Procedure: For patients enrolled in JBT group, a monorail balloon is placed at the ostium of SB to protect the SB before the stent in main branch(MB) is deployed. Only a PTCA wire would be placed in the SB while stenting MB for patients randomized in JWT group. Only drug-eluting stent should be implanted in the target vessel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jailed-balloon technique | Experimental | Procedure: Jailed-balloon techniqueApply jailed-balloon technique to protect the side branch during coronary bifurcation PCI |
| Jailed-wire technique | Active comparator | Procedure: Jailed-wire techniqueApply jailed-wire technique to protect the side branch during coronary bifurcation PCI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years and ≤75 years;
- De novo Medina 1,1,1 coronary bifurcation with a main branch(MB) >2.5mm while side branch <2.5mm and >1.5mm;
- Only one bifurcation lesion need to be treated in one vessel;
- The target lesion in MB has stenosis more than 75% or fractional flow reserve(FFR) less than 0.75 and the stenosis in SB ostium is more than 50%;
- Signed consent is obtained.
Key exclusion criteria (13 listed)
- Left ventricular ejection fraction(LVEF) less than 30%;
- Hemodynamic instability or cardiac shock;
- Myopathy or muscular injury with elevation of creatine kinase to more than 3mg/dL;
- Tumor with expected survival less than 1 year;
- Autoimmune disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jailed-balloon techniqueA monorail balloon is placed in the side branch(SB) before the stent in main branch(MB) is deployed. After MB stent is deployed to nominal pressure, the balloon in SB is inflated to 3 atm generally but to higher pressure to perform angioplasty if the blood flow in SB is compromised. The balloon in SB is then removed while the wire in SB is left in place. The MB stent balloon is inflated again for stent apposition. The SB wire is left in place to facilitate rewiring if the blood flow in SB is compromised. Otherwise the SB wire is removed after the stent balloon is inflated again. | Procedure or surgery | Jailed-balloon technique |
| Jailed-wire techniqueA percutaneous transluminal coronary angioplasty(PTCA) wire is placed in the side branch(SB) before the stent in main branch(MB) is deployed. After MB stent is deployed to some pressure to achieve full apposition, the wire in SB is left in place to facilitate rewiring if the blood flow in SB is compromised. Otherwise the SB wire is removed after the MB stent is deployed. | Procedure or surgery | Jailed-wire technique |
Primary outcome
Side branch(SB) loss and PCI related myocardial infarction
Time frame: Within 48 hours after PCI
The primary outcome of the study is a composite of SB loss or PCI related myocardial infarction. According to Thrombolysis in Myocardial Infarction (TIMI) flow grading system, SB loss is defined as less than TIMI 3 flow immediately following MB stenting. It is considered temporary SB loss if TIMI 3 flow is restored with angioplasty and/or stenting. Otherwise, SB loss is considered permanent. In patients with normal (≤99th percentile URL) baseline cardiac troponin(cTn) concentrations, PCI related myocardial infarction is defined as elevations of cTn >5× 99th percentile URL occurring within 48 hours of the procedure, which should be accompanied with other evidence of myocardial injury. A rise of >20% is required for the diagnosis of PCI related myocardial infarction if the baseline cTn values are elevated and are stable or falling.
2 secondary outcomes
Major adverse cardiovascular events(MACEs)
Time frame: Within 1 year after PCI
PCI related complication
Time frame: Immediately after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
- Background: PubMed 19962049Sharma SK, Sweeny J, Kini AS. Coronary bifurcation lesions: a current update. Cardiol Clin. 2010 Feb;28(1):55-70. doi: 10.1016/j.ccl.2009.10.001.
- Background: PubMed 19463303Latib A, Colombo A. Bifurcation disease: what do we know, what should we do? JACC Cardiovasc Interv. 2008 Jun;1(3):218-26. doi: 10.1016/j.jcin.2007.12.008.
- Background: PubMed 23420654Depta JP, Patel Y, Patel JS, Novak E, Yeung M, Zajarias A, Kurz HI, Lasala JM, Bach RG, Singh J. Long-term clinical outcomes with the use of a modified provisional jailed-balloon stenting technique for the treatment of nonleft main coronary bifurcation lesions. Catheter Cardiovasc Interv. 2013 Nov 1;82(5):E637-46. doi: 10.1002/ccd.24778. Epub 2013 Jul 30.
- Background: PubMed 20058502Colombo F, Biondi-Zoccai G, Infantino V, Omede P, Moretti C, Sciuto F, Siliquini R, Chiado S, Trevi GP, Sheiban I. A long-term comparison of drug-eluting versus bare metal stents for the percutaneous treatment of coronary bifurcation lesions. Acta Cardiol. 2009 Oct;64(5):583-8. doi: 10.2143/AC.64.5.2042686.
- Background: PubMed 22364484Singh J, Patel Y, Depta JP, Mathews SJ, Cyrus T, Zajarias A, Kurz HI, Lasala JM, Bach RG. A modified provisional stenting approach to coronary bifurcation lesions: clinical application of the "jailed-balloon technique". J Interv Cardiol. 2012 Jun;25(3):289-96. doi: 10.1111/j.1540-8183.2011.00716.x. Epub 2012 Feb 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiyan Chen, Doctor study chair
Guangdong Provincial People's Hospital
Jianfang Luo, Doctor study director
Guangdong Provincial People's Hospital
Pengcheng He, Doctor principal investigator
Guangdong Provincial People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jailed-balloon technique and Jailed-wire technique in people with Coronary Artery Disease, run by Guangdong Provincial People's Hospital at 2 sites in China.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 19 Jun 2014. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pengcheng He, Doctor (86-20-83827812 ext. 10580, he_peng_cheng@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side branch(SB) loss and PCI related myocardial infarction (time frame: Within 48 hours after PCI). 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 NCT02167230, which also lists 5 linked publications.
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 19 Jun 2014.