Back to resultsEverolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease (ABSORB-LONG)
Primary Purpose
Percutaneous Transluminal Coronary Angioplasty
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
everolimus-eluting bioresorbable vascular (Absorb) scaffold
everolimus-eluting cobalt-chromium (Xience) stent
Sponsored by
About this trial
This is an interventional treatment trial for Percutaneous Transluminal Coronary Angioplasty focused on measuring bioresorbable vascular scaffold, coronary artery disease
Eligibility Criteria
Inclusion Criteria:
- Age 18 and more
- Diffuse long native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 40 mm requiring at least 2 overlapped stents with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment
- Patients with silent ischemia, stable or unstable angina pectoris, and acute myocardial infarction including NSTEMI or STEMI
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site
Exclusion Criteria:
- Subject has known hypersensitivity or contraindication to device material and its ingredients (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated
- Subject has known allergic reaction, hypersensitivity, or contraindication to aspirin; to clopidogrel and prasugrel and ticagrelor; or to heparin and therefore cannot be adequately treated with study medication
- An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 12 m after the procedure
- STEMI requiring primary percutaneous coronary intervention
- Cardiogenic shock
- Restenotic lesions
- Left main
- Extreme angulation (≥90°) or excessive tortuosity (≥two 45° angles) proximal to or within the target lesion
- Heavy calcification proximal to or within the target lesion
- Compromised left ventricular dysfunction (LVEF <30%)
- At the time of screening, the subject has a malignancy that is not in remission
- Terminal illness with life expectancy <1 year
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
- Patient's pregnant or breast-feeding or child-bearing potential
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ABSORB BVS
XIENCE EES
Arm Description
Outcomes
Primary Outcome Measures
Target lesion failure
event rate for composite of cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-lesion revascularization
Secondary Outcome Measures
Cardiac death
Target-vessel myocardial infarction
Ischemia-driven target-lesion revascularization
All-cause mortality
event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction
Any revascularization
Any revascularization; target lesion vs. nontarget lesion, target vessel vs. nontarget vessel, ischemia-driven vs. not ischemia-driven
Target-vessel failure
death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization
Stent thrombosis
event rate of device success or procedural success
Device success defined as angiographic evidence of <30% final residual stenosis of the target lesion.
Procedural success is defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death.
Patient-reported angina status measured by Seattle angina questionnaire
Full Information
NCT ID
NCT02831205
First Posted
July 6, 2016
Last Updated
December 14, 2017
Sponsor
Duk-Woo Park, MD
Collaborators
CardioVascular Research Foundation, Korea
1. Study Identification
Unique Protocol Identification Number
NCT02831205
Brief Title
Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease
Acronym
ABSORB-LONG
Official Title
Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to current BVS safety issue
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Duk-Woo Park, MD
Collaborators
CardioVascular Research Foundation, Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Transluminal Coronary Angioplasty
Keywords
bioresorbable vascular scaffold, coronary artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ABSORB BVS
Arm Type
Experimental
Arm Title
XIENCE EES
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
everolimus-eluting bioresorbable vascular (Absorb) scaffold
Other Intervention Name(s)
ABSORB BVS
Intervention Type
Device
Intervention Name(s)
everolimus-eluting cobalt-chromium (Xience) stent
Other Intervention Name(s)
XIENCE EES
Primary Outcome Measure Information:
Title
Target lesion failure
Description
event rate for composite of cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-lesion revascularization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cardiac death
Time Frame
5 years
Title
Target-vessel myocardial infarction
Time Frame
5 years
Title
Ischemia-driven target-lesion revascularization
Time Frame
5 years
Title
All-cause mortality
Time Frame
5 years
Title
event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction
Time Frame
5 years
Title
Any revascularization
Description
Any revascularization; target lesion vs. nontarget lesion, target vessel vs. nontarget vessel, ischemia-driven vs. not ischemia-driven
Time Frame
5 years
Title
Target-vessel failure
Description
death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization
Time Frame
5 years
Title
Stent thrombosis
Time Frame
5 years
Title
event rate of device success or procedural success
Description
Device success defined as angiographic evidence of <30% final residual stenosis of the target lesion.
Procedural success is defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death.
Time Frame
5 years
Title
Patient-reported angina status measured by Seattle angina questionnaire
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 and more
Diffuse long native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 40 mm requiring at least 2 overlapped stents with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment
Patients with silent ischemia, stable or unstable angina pectoris, and acute myocardial infarction including NSTEMI or STEMI
The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site
Exclusion Criteria:
Subject has known hypersensitivity or contraindication to device material and its ingredients (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated
Subject has known allergic reaction, hypersensitivity, or contraindication to aspirin; to clopidogrel and prasugrel and ticagrelor; or to heparin and therefore cannot be adequately treated with study medication
An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 12 m after the procedure
STEMI requiring primary percutaneous coronary intervention
Cardiogenic shock
Restenotic lesions
Left main
Extreme angulation (≥90°) or excessive tortuosity (≥two 45° angles) proximal to or within the target lesion
Heavy calcification proximal to or within the target lesion
Compromised left ventricular dysfunction (LVEF <30%)
At the time of screening, the subject has a malignancy that is not in remission
Terminal illness with life expectancy <1 year
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
Patient's pregnant or breast-feeding or child-bearing potential
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This is not a publicly funded trial.
Learn more about this trial
Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease
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