Back to resultsThe Study of Active Transfer of Plaque Technique for Unprotected Distal Left Main Bifurcation Lesions
Primary Purpose
Coronary Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sirolimus eluting Drug stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring unprotected distal left main bifurcation lesion, Percutaneous coronary intervention, clinical study, Active Transfer of Plaque （ATP）, Provisional T Stenting
Eligibility Criteria
Inclusion Criteria:
- Patient must be at least ≥18, ≤80 years of age.
- Patient has Stable/unstable angina or NSTEMI
- Patient has STEMI>24-hour from the onset of chest pain to admission.
- LMb (Medina 0,1,1；1,1,1；0,1,0 ；1,1,0).
- Patient is eligible for elective percutaneous coronary intervention (PCI) .
- Patient is an acceptable candidate for coronary artery bypass grafting (CABG).
- Patient (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; patient is willing to comply with all protocol-required follow-up evaluations
Exclusion Criteria:
- Patient with STEMI (within 24-hour from the onset of chest pain to admission).
- Patient has known allergy to the study stent system or protocol-required concomitant medications that cannot be adequately pre-medicated (everolimus, aspirin, contrast media, acrylic acid, Stainless steel).
- Patient has intolerable to dual anti-platelet therapy.
- Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
- Patient is pregnant or nursing.
- Patient is participating in another clinical trial that has not reached its primary endpoint within 12 months after the index procedure.
- Patient with severe calcified lesions needing rotational atherectomy.
- Left main In Stent Restenosis.
- Investigator consider that patients don't fit to participate in the study.
Sites / Locations
- Beijing Anzhen Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ATP technique
Provisional T stenting technique
Arm Description
This arm plan to enroll 158 subjects，Sirolimus-eluting Drug stent implantation via Active transfer of Plaque technique in the treatment of unprotected distal left main bifurcation lesions.In the ATP technique treatment of bifurcation lesions, by the balloon pre-dilation in the target side branch, the plaque will be actively transferred from side branch to main vessel. Subsequently, the plaque will be fixed by the expansive stent in main vessel. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI or stent in SB is recommended if there is at least one of following: residual stenosis>70%, >type B dissection and TIMI flow<3.
This arm plan to enroll 158 subjects.Sirolimus-eluting Drug stent implantation via Provisional T Stenting technique in the treatment of unprotected distal left main bifurcation lesions.Provisional T stenting technique is the typic step-T stenting. In brief, two wires are advanced to distal MV and SB. Pre dilation is left at operator's discretion, however, pre dilating SB is not encouraged. Kissing balloon inflation before stenting MV is left at operator's discretion. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI is recommended if there is at least one of following: residual stenosis>70%, >type B dissection and TIMI flow<3.
Outcomes
Primary Outcome Measures
Rate of target lesion revascularization (TLR) at 12-month.
Secondary Outcome Measures
Rate of target lesion failure(TLF) at 1-, 6-,12- and 24-month after procedure
Clinically cardiovascular endpoints at 1-, 6- , 12- and 24-month, including all-cause death, MI and any revascularization.
Stent thrombosis which is defined according to Academic Research Consortium (ARC) definition, including definite, probable and possible stent thrombosis.
Classification score of Canadian Cardiovascular Society (CCS) angina or Braunwald class.
The net gain of lumen diameter; in-segment late loss (LL) and ISR of main vessel and side branch at 13-month.
Full Information
NCT ID
NCT02127138
First Posted
April 27, 2014
Last Updated
January 13, 2020
Sponsor
Beijing Anzhen Hospital
Collaborators
Beijing Jishuitan Hospital, Tianjin First Central Hospital, Tianjin Chest Hospital, Taihe Hospital, The Fourth Affiliated Hospital of Harbin Medical University, General Hospital of Ningxia Medical University, Tangshan Worker's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02127138
Brief Title
The Study of Active Transfer of Plaque Technique for Unprotected Distal Left Main Bifurcation Lesions
Official Title
A Prospective Multicenter Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
Collaborators
Beijing Jishuitan Hospital, Tianjin First Central Hospital, Tianjin Chest Hospital, Taihe Hospital, The Fourth Affiliated Hospital of Harbin Medical University, General Hospital of Ningxia Medical University, Tangshan Worker's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions
Detailed Description
It is a prospective, multi-center, randomized, open-label, non-inferiority trial. A total of 316 subjects from around 20 selected hospitals will be randomized on a 1:1 basis to either Active transfer of Plaque (ATP) stenting technique or Provisional T stenting technique.
In the ATP treatment of bifurcation lesions, by the balloon pre-dilation in the target side branch, the plaque will be actively transferred from side branch to main vessel. Subsequently, the plaque will be fixed by the expansive stent in main vessel.As to the provisional T treatment, provisional T stenting is the typic step-T stenting. In brief, two wires are advanced to distal MV and SB. Pre dilation is left at operator's discretion, however, pre dilating SB is not encouraged. Kissing balloon inflation before stenting MV is left at operator's discretion. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI is recommended if there is at least one of following: residual stenosis>70%, >type B dissection and TIMI flow<3.
All patients will be followed clinically at 1-, 6- 12- and 24-month after stent implantation. Repeat angiography will be performed in all patients at 13 months after the index procedure.
The primary endpoint of the trial is the rate of TLR at 12-month follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
unprotected distal left main bifurcation lesion, Percutaneous coronary intervention, clinical study, Active Transfer of Plaque （ATP）, Provisional T Stenting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
316 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ATP technique
Arm Type
Experimental
Arm Description
This arm plan to enroll 158 subjects，Sirolimus-eluting Drug stent implantation via Active transfer of Plaque technique in the treatment of unprotected distal left main bifurcation lesions.In the ATP technique treatment of bifurcation lesions, by the balloon pre-dilation in the target side branch, the plaque will be actively transferred from side branch to main vessel. Subsequently, the plaque will be fixed by the expansive stent in main vessel. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI or stent in SB is recommended if there is at least one of following: residual stenosis>70%, >type B dissection and TIMI flow<3.
Arm Title
Provisional T stenting technique
Arm Type
Active Comparator
Arm Description
This arm plan to enroll 158 subjects.Sirolimus-eluting Drug stent implantation via Provisional T Stenting technique in the treatment of unprotected distal left main bifurcation lesions.Provisional T stenting technique is the typic step-T stenting. In brief, two wires are advanced to distal MV and SB. Pre dilation is left at operator's discretion, however, pre dilating SB is not encouraged. Kissing balloon inflation before stenting MV is left at operator's discretion. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI is recommended if there is at least one of following: residual stenosis>70%, >type B dissection and TIMI flow<3.
Intervention Type
Device
Intervention Name(s)
Sirolimus eluting Drug stent
Intervention Description
Use the Sirolimus-eluting Drug stents has been approved by the CFDA，But does not allow use taxol-eluting Drug stents and Drug-eluting stent without Polymer.
Primary Outcome Measure Information:
Title
Rate of target lesion revascularization (TLR) at 12-month.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of target lesion failure(TLF) at 1-, 6-,12- and 24-month after procedure
Time Frame
Up to 2years
Title
Clinically cardiovascular endpoints at 1-, 6- , 12- and 24-month, including all-cause death, MI and any revascularization.
Time Frame
Up to 2 years
Title
Stent thrombosis which is defined according to Academic Research Consortium (ARC) definition, including definite, probable and possible stent thrombosis.
Time Frame
Up to 2 years
Title
Classification score of Canadian Cardiovascular Society (CCS) angina or Braunwald class.
Time Frame
Up to 2 years
Title
The net gain of lumen diameter; in-segment late loss (LL) and ISR of main vessel and side branch at 13-month.
Time Frame
13 months
Other Pre-specified Outcome Measures:
Title
The release of procedure-related biomarker
Time Frame
baseline
Title
Consumption of devices for surgery procedure
Time Frame
baseline
Title
Amount of contrast agent
Time Frame
baseline
Title
Procedure time
Time Frame
baseline
Title
X-ray exposure time
Time Frame
baseline
Title
X-ray dose
Time Frame
baseline
Title
DAP-total, DAP-record, DAP-fluoro
Time Frame
baseline
Title
contrast induced acute kidney injury (CIAKI)
Time Frame
3 days after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must be at least ≥18, ≤80 years of age.
Patient has Stable/unstable angina or NSTEMI
Patient has STEMI>24-hour from the onset of chest pain to admission.
LMb (Medina 0,1,1；1,1,1；0,1,0 ；1,1,0).
Patient is eligible for elective percutaneous coronary intervention (PCI) .
Patient is an acceptable candidate for coronary artery bypass grafting (CABG).
Patient (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; patient is willing to comply with all protocol-required follow-up evaluations
Exclusion Criteria:
Patient with STEMI (within 24-hour from the onset of chest pain to admission).
Patient has known allergy to the study stent system or protocol-required concomitant medications that cannot be adequately pre-medicated (everolimus, aspirin, contrast media, acrylic acid, Stainless steel).
Patient has intolerable to dual anti-platelet therapy.
Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
Patient is pregnant or nursing.
Patient is participating in another clinical trial that has not reached its primary endpoint within 12 months after the index procedure.
Patient with severe calcified lesions needing rotational atherectomy.
Left main In Stent Restenosis.
Investigator consider that patients don't fit to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yujie Zhou, MD, PhD
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Study of Active Transfer of Plaque Technique for Unprotected Distal Left Main Bifurcation Lesions
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