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H-Side Branch Stent, A New Stent for the Treatment of True Bifurcation Lesions

Primary Purpose

Coronary Artery Disease

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

H-side branch stent

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Side branch stent, Coronary bifurcation lesion

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Older than 20 years old
Patient with angina or asymptomatic ischemic cardiomyopathy who is required to be treated with stent at coronary bifurcation lesion
Bifurcation lesion with 2.5~4.0mm of main vessel diameter, <30mm of main vessel length and ≥2.0mm of branched vessel diameter

Exclusion Criteria:

Acute myocardial infarction
Confirmed or suspicious presence of thrombus in target lesion
In-stent restenosis lesion
Visual angulation with ≥75°
Lesion with severe calcification or severe tortuosity
Left main lesion
Chronic total occlusion lesion
Graft lesion
Contraindication to antiplatelet drugs
Left ventricular dysfunction (LVEF ≤40%)
Severe hepatic dysfunction (≥2.5 times than reference of AST or ALT)
Renal dysfunction (serum Creatinine > 2.0mg/dL)
History of cerebral hemorrhage, pulmonary or gastrointestinal bleeding
Hypersensitivity of aspirin, clopidogrel or contrast media
Pregnant woman or possibility of pregnancy during clinical study period

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

H-side branch stent

Arm Description

H-side branch stent group

Outcomes

Primary Outcome Measures

Major adverse cardiovascular events

composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, target lesion revascularization

Secondary Outcome Measures

Full Information

NCT ID

NCT02037386

First Posted

January 13, 2014

Last Updated

January 7, 2015

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02037386

Brief Title

H-Side Branch Stent, A New Stent for the Treatment of True Bifurcation Lesions

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Withdrawn

Why Stopped

problem with balloon catheter

Study Start Date

February 2014 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Intervention for coronary bifurcation lesion is about 10~20% of entire percutaneous coronary intervention (PCI). Bifurcation lesion is difficult to be treated and prognosis of PCI at bifurcation lesion has been poorer compared to that at non-bifurcation lesion. Furthermore, occlusion of side branch frequently occurred during PCI. Several techniques to prevent occlusion of side branch have been developed, but outcomes are not to be satisfied. H-side branch stent is developed to treat coronary side branch lesion and composed of proximal, connecting and distal parts. In vivo study performed in pigs showed effective H-side branch stent. This study is to confirm safety and efficacy of H-side branch stent for treatment of coronary side branch lesion.

6. Conditions and Keywords

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

Coronary Artery Disease

Keywords

Side branch stent, Coronary bifurcation lesion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

H-side branch stent

Arm Type

Experimental

Arm Description

H-side branch stent group

Intervention Type

Device

Intervention Name(s)

H-side branch stent

Intervention Description

Implantation of H-side branch stent at coronary bifurcation stenotic lesion

Primary Outcome Measure Information:

Title

Major adverse cardiovascular events

Description

composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, target lesion revascularization

Time Frame

During 6 months after implantation of H-side branch stent

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Older than 20 years old Patient with angina or asymptomatic ischemic cardiomyopathy who is required to be treated with stent at coronary bifurcation lesion Bifurcation lesion with 2.5~4.0mm of main vessel diameter, <30mm of main vessel length and ≥2.0mm of branched vessel diameter Exclusion Criteria: Acute myocardial infarction Confirmed or suspicious presence of thrombus in target lesion In-stent restenosis lesion Visual angulation with ≥75° Lesion with severe calcification or severe tortuosity Left main lesion Chronic total occlusion lesion Graft lesion Contraindication to antiplatelet drugs Left ventricular dysfunction (LVEF ≤40%) Severe hepatic dysfunction (≥2.5 times than reference of AST or ALT) Renal dysfunction (serum Creatinine > 2.0mg/dL) History of cerebral hemorrhage, pulmonary or gastrointestinal bleeding Hypersensitivity of aspirin, clopidogrel or contrast media Pregnant woman or possibility of pregnancy during clinical study period

12. IPD Sharing Statement

Citations:

PubMed Identifier

20040003

Citation

Hong MK, Shim JM, Youn YJ, Lee KH, Kim JS, Ko YG, Lee SH, Choi D, Yoon J, Jang Y. A new stent design for the treatment of true bifurcation lesions: H-side branch stents. J Interv Cardiol. 2010 Feb;23(1):54-9. doi: 10.1111/j.1540-8183.2009.00519.x. Epub 2009 Dec 17.

Results Reference

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H-Side Branch Stent, A New Stent for the Treatment of True Bifurcation Lesions

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