SPIRIT Small Vessel Registry
- Conditions
- Myocardial IschemiaCoronary Artery DiseaseAtherosclerosis
- Interventions
- Device: 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System
- Registration Number
- NCT00783796
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
To evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial vessel.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 2.25mm XIENCE V® 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System Patients receiving the 2.25 mm XIENCE V® stent
- Primary Outcome Measures
Name Time Method Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR). 3 years This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.
- Secondary Outcome Measures
Name Time Method Target Vessel MI - Q-wave and Non Q-wave (Per ARC) 3 years ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Cardiac Death/MI 3 years This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.
All Coronary Revascularization (TVR and Non-TVR) 3 years Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel (per protocol).
Clinically Indicated Target Vessel Revascularization 3 years Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).
In-Stent Late Loss 240 days In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up.
Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap) From start of index procedure to end of index procedure Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of \<50%.
Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions) From the start of index procedure to end of index procedure Achievement of a final in-stent diameter stenosis of \<50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days.
In-segment Late Loss (LL) 240 Days In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.
Proximal Late Loss 240 days Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement).
Distal Late Loss 240 days Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement).
In-stent % Diameter Stenosis 240 days Value calculated as 100\*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter.
Proximal % Diameter Stenosis 240 days Value calculated as 100\*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement.
In-stent Angiographic Binary Restenosis (ABR) Rate 240 days Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up.
Clinically Indicated Target Vessel Revascularization (TVR) 30 days Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) 3 years ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) 3 years Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
All TVR (CI and Non-CI) 3 years Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure (per protocol).
All TLR (CI and Non-CI) 3 years Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated (per protocol).
In-segment % Diameter Stenosis 240 days Value calculated as 100\*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter.
Distal % Diameter Stenosis 240 days Value calculated as 100\*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement.
In-segment Angiographic Binary Restenosis (ABR) Rate 240 days Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up.
Stent Thrombosis (ARC Defined) Overall (0 - 1123 days) Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Stent Thrombosis (Protocol Defined) Overall (0 - 1123 days) Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (\>1 day and ≤30 days), and late (\>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction\* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (\*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
All Death/ All MI/All Coronary Revascularization 3 years This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.
Clinically Indicated Target Lesion Revascularization (CI-TLR) 3 years Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).
Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) 3 years Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Proximal Angiographic Binary Restenosis (ABR) Rate 240 days Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up.
Distal Angiographic Binary Restenosis (ABR) Rate 240 days Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up.
All Death (Cardiac, Vascular, Non-cardiovascular) 3 years All death, including death from cardiac, vascular, and non-cardiovascular causes (per protocol).
Cardiac Death/ All MI /CI-TLR 3 years This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).
Trial Locations
- Locations (34)
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
St. Joseph Medical Center
🇺🇸Towson, Maryland, United States
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Mother Frances Hospital
🇺🇸Tyler, Texas, United States
Gotham Cardiovascular Reasearch, PC. (St. Vincent's Medical Center-closing, pts moved)
🇺🇸New York, New York, United States
St. Patrick Hospital
🇺🇸Missoula, Montana, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
St. Joseph Mercy Hospital
🇺🇸Ypsilanti, Michigan, United States
Hillcrest Medical Center
🇺🇸Tulsa, Oklahoma, United States
EMH Regional Medical Center
🇺🇸Elyria, Ohio, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
St. Anthony Hospital
🇺🇸Rockford, Illinois, United States
Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
WakeMed Hospital
🇺🇸Raleigh, North Carolina, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Northwest Texas Healthcare System
🇺🇸Amarillo, Texas, United States
St. Joseph Hospital
🇺🇸Bellingham, Washington, United States
Overlake Hospital Medical Center
🇺🇸Bellevue, Washington, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Baptist West Hospital
🇺🇸Knoxville, Tennessee, United States
Scottsdale Healthcare
🇺🇸Scottsdale, Arizona, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Cooper Health System
🇺🇸Camden, New Jersey, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
St. Cloud Hospital
🇺🇸Saint Cloud, Minnesota, United States
St. John's Hospital / Prairie Education & Research Cooperative
🇺🇸Springfield, Illinois, United States