Jailed-balloon Technique in Coronary Bifurcation Lesion PCI

Coronary Artery Disease Clinical Trial

— JBTinCBL  

Official title:

Effect of Jailed-Balloon Technique in Percutaneous Coronary Intervention for Non-Left Main Coronary Bifurcation Lesions: A Prospective, Randomized Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02167230
• Other study ID #: JBT
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2014
• Last updated: June 17, 2014
• Start date: October 2014
• Est. completion date: September 2017

Study information

• Verified date: June 2014
• Source: Guangdong General Hospital
• Contact: Pengcheng He, Doctor
• Phone: 86-20-83827812
• Email: he_peng_cheng[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical 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 cardiovascular events(MACEs).

Description:

1. Objective: To compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.

2. Background: Solid evidence is scant to compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.

3. Study design: This is a multi-center, prospective, randomized study.

4. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 410
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age =18 years and =75 years;

2. De novo Medina 1,1,1 coronary bifurcation with a main branch(MB) >2.5mm while side branch <2.5mm and >1.5mm;

3. Only one bifurcation lesion need to be treated in one vessel;

4. 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%;

5. Signed consent is obtained.

Exclusion Criteria:

1. Left ventricular ejection fraction(LVEF) less than 30%;

2. Hemodynamic instability or cardiac shock;

3. Myopathy or muscular injury with elevation of creatine kinase to more than 3mg/dL;

4. Tumor with expected survival less than 1 year;

5. Autoimmune disease;

6. Active gastrointestinal bleeding or any contraindication for dual antiplatelet therapy;

7. Acute coronary syndrome require emergency PCI;

8. Coronary bifurcation need to be treated with two-stent strategy;

9. Not suitable for drug-eluting stent(DES) implantation;

10. Mental disorder or alcohol dependence;

11. PCI or coronary artery bypass graft (CABG) within 6 months before enrollment;

12. Target lesion is in-stent restenosis;

13. Women in gestation period or lactation period or human chorionic gonadotropin (HCG) urine test positive.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Jailed-balloon technique
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 technique
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.

Locations

Country	Name	City	State
China	Kashgar District 1st People's Hospital	Kashgar	Xinjiang
China	Shenzhen People's Hospital	Shenzhen	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Guangdong General Hospital	Kashgar District 1st People's Hospital, Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Colombo F, Biondi-Zoccai G, Infantino V, Omedé P, Moretti C, Sciuto F, Siliquini R, Chiadò 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. — View Citation

Depta 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. — View Citation

Latib 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. Review. — View Citation

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. Review. — View Citation

Singh 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 48 hours after PCI	No
Secondary	Major adverse cardiovascular events(MACEs)	MACEs is a composite end point including cardiac death, non fatal myocardial infarction and target vessel revascularization(TVR).	Within 1 year after PCI	No
Secondary	PCI related complication	PCI related complication include coronary dissection, coronary perforation, device dislodgement, device entrapment and device rupture.	Immediately after PCI	Yes