SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
- Conditions
- StentsCoronary Artery DiseaseTotal Coronary OcclusionCoronary Artery RestenosisStent ThrombosisVascular DiseaseMyocardial IschemiaCoronary Artery Stenosis
- Interventions
- Device: XIENCE V® Everolimus Eluting Coronary StentDevice: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Registration Number
- NCT00180479
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
This study is divided into 5 arms:
1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System
2. US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS
3. US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS
4. US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS
5. Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan
The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston Scientific.
- Detailed Description
The purpose of the SPIRIT III clinical trial is to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS). The XIENCE V® EECS (XIENCE V® arm) will be compared to an active control group represented by the FDA approved commercially available Boston Scientific TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System (TAXUS® arm).
The SPIRIT III clinical trial consists of a randomized clinical trial (RCT) in the US which will enroll approximately 1,002 subjects (2:1 randomization XIENCE V® EECS : TAXUS® EXPRESS2™ PECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes \>= 2.5 mm and \<= 3.75 mm.
The SPIRIT III clinical trial also consists of three concurrent US non-randomized arms (2.25 mm diameter stent, 4.0 mm diameter stent and 38 mm length stent arms) and one Japanese non-randomized arm as follows:
1. 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes \> 2.25 mm and \< 2.5 mm and lesion length \<= 22 mm will be enrolled concurrently in the US 2.25 mm non-randomized treatment arm
2. 80 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes \> 3.75 mm and \>= 4.25 mm and lesion length \<= 28 mm will be enrolled concurrently in the US 4.0 mm non-randomized treatment arm
3. 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes \> 3.0 mm and \< 4.25 mm and lesion length \> 24 mm and \< 32 mm will be enrolled concurrently in the US 38 mm non-randomized treatment arm.
4. 88 Japanese subjects with a maximum of two de novo native coronary artery lesions within vessel sizes \>= 2.5 mm and \<= 4.25 mm and lesion length \<= 28 mm will be enrolled concurrently in the non-randomized Japanese arm.
All subjects in the RCT and the four non-randomized arms will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the TAXUS® arm of US RCT.
Subjects enrolled in the US RCT will be sub-grouped based on whether they will have an angiographic and/or an intravascular ultrasound (IVUS) follow-up at 240 days as follows:
Group A: Angiographic and IVUS follow-up at 240 days (N=240) Group B: Angiographic follow-up at 240 days (N=324) Group C: No angiographic or IVUS follow-up (N=438)
All subjects will have clinical follow-up at 30, 180, 240 and 270 days (Data collected through 270 days will be submitted as the primary data set for US and Japanese market approval), and 1, 2, 3, 4, and 5 years (for annual reports).
All subjects enrolled into three US non-randomized arms (N=105 for 2.25 mm arm, N=80 for 4.0 mm arm and N=105 for 38 mm stent arm) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic follow-up at 240 days. No IVUS follow-up is required for subjects enrolled in these arms.
All subjects enrolled into the Japanese non-randomized arm (N=88) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic and IVUS follow-up at 240 days.
All subjects who receive a bailout stent will be assigned to Group A follow-up subgroup (angiographic and IVUS follow-up at 240 days after the index procedure), regardless of their primary assignment at randomization. At sites without IVUS capability, subjects receiving bailout stent will be assigned to Group B follow-up subgroup (angiographic follow-up at 240 days after the index procedure). Angiographic follow-up is required for all bailout subjects at 240 days.
Data from the US RCT will be submitted to the FDA as the primary data set for product approval for RVD \>= 2.5 mm and \<= 3.75 mm (2.5 mm, 3.0 mm and 3.5 mm stents). Combined data of the US trial/Japanese non-randomized arm will be submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) for Japanese approval for RVD\>=2.5 mm and \<= 4.25 mm (2.5 mm, 3.0 mm 3.5 mm and 4.0 mm stents). Data from the Japanese non-randomized arm will be submitted to the FDA as additional safety data. Data from the US non-randomized arms of the trial will be the primary data sets for approval for 2.25 mm diameter stent (RVD \> 2.25 mm and \< 2.5 mm), 4.0 mm diameter stent (RVD \> 3.75 mm and \<= 4.25 mm) and 38 mm length stent (RVD \> 3.0 mm and \<= 4.25 mm and lesion length \> 24 mm and \<= 32 mm), respectively in the US.
A pharmacokinetic substudy will be carried out in a minimum of 5 pre-determined sites in the US and a minimum of 5 pre-determined sites in Japan. In the US, the pharmacokinetics (PK) of everolimus, as delivered by the XIENCE V® EECS will be analyzed in a subset of 15 subjects (minimum) with single vessel/lesion treatment, and up to 20 subjects with dual vessel/lesion treatment, respectively. In Japan, a minimum of 10 subjects with single vessel/lesion treatment and up to 20 subjects with dual vessel/lesion treatment will have a PK measurements performed. These subsets will include subjects receiving overlapping stents.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1002
- Target lesion(s) must be located in a native epicardial vessel with visually estimated diameter between >= 2.25 mm and <= 4.25 mm and a lesion length <= 32 mm
- The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of >= 1
- Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure (subjects who received brachytherapy will be excluded from the trial)
- Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
- Lesion involving a bifurcation >= 2 mm in diameter or ostial lesion > 50% stenosed by visual estimation or side branch requiring predilatation
- Located in a major epicardial vessel that has been previously treated with brachytherapy
- Located in a major epicardial vessel that has been previously treated with percutaneous intervention < 9 months prior to index procedure
- Total occlusion (TIMI flow 0), prior to wire passing
- The target vessel contains thrombus
- Another significant lesion (> 40% diameter stenosis [DS]) is located in the same epicardial vessel as the target lesion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 XIENCE V® Everolimus Eluting Coronary Stent XIENCE V® Everolimus Eluting Coronary Stent System 2 TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent TAXUS® EXPRESS2™Paclitaxel Eluting Coronary Stent System
- Primary Outcome Measures
Name Time Method Primary Endpoint: In-segment Late Loss (LL) 240 days In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.
- Secondary Outcome Measures
Name Time Method Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF) 270 days The composite endpoint comprised of:
* Cardiac death (death in which a cardiac cause cannot be excluded)
* Myocardial infarction (MI, classified as Q-wave and non-Q wave)
* Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
* Ischemia-driven target vessel revascularization (TVR) by CABG or PCITarget Vessel Failure (TVF) 5 years The composite endpoint comprised of:
* Cardiac death (death in which a cardiac cause cannot be excluded)
* Myocardial infarction (MI, classified as Q-wave and non-Q wave)
* Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
* Ischemia-driven target vessel revascularization (TVR) by CABG or PCIIschemia Driven Target Lesion Revascularization (ID-TLR) 5 years Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional studyIschemia Driven Target Vessel Revascularization (ID-TVR) 5 years Revascularization at the target vessel associated with any of the following
* Positive functional ischemia study
* Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
* Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse EventsIschemia Driven Major Adverse Cardiac Event (MACE) 5 years The composite endpoint comprised of:
* Cardiac death
* Myocardial infarction (MI, classified as Q-wave and non-Q wave)
* Ischemia-driven target lesion revascularization (TLR) by CABG or PCIIschemia Driven Major Adverse Cardiac Event(MACE) 2 years The composite endpoint comprised of:
* Cardiac death
* Myocardial infarction (MI, classified as Q-wave and non-Q wave)
* Ischemia-driven target lesion revascularization (TLR) by CABG or PCIIn-stent % Angiographic Binary Restenosis (% ABR) Rate at 240 days Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)
In-segment % Angiographic Binary Restenosis (% ABR) Rate 240 days Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA
Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection at 240 days Incomplete Apposition (Persisting \& Late acquired): Failure to completely appose vessel wall w/ ≥1 strut separated from vessel wall w/ blood behind strut per ultrasound. Aneurysm: Abnormal vessel expansion ≥ 1.5 of reference vessel diameter. Thrombus: Protocol \& ARC definition.
Persisting dissection @ follow-up, present post-procedure.Acute Success: Clinical Device In-hospital Successful delivery and deployment of 1st implanted study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis \< 50%.
Acute Success: Clinical Procedure In-hospital Successful delivery and deployment of study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis \< 50%.
Proximal Late Loss at 240 days Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement)
Distal Late Loss 240 days Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)
In-stent Late Loss at 240 days In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)
% Volume Obstruction (% VO) at 240 days Defined as stent intimal hyperplasia and calculated as 100\*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.
In-stent % Diameter Stenosis (% DS) at 240 days In-stent: Within the margins of the stent, the value calculated as 100 \* (1 - in-stent MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
In-segment % Diameter Stenosis (% DS) 240 days Within the margins of the stent, 5 mm proximal and 5 mm distal to the stent, the value calculated as 100 \* (1 - in-segment MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Trial Locations
- Locations (64)
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
St. Patrick Hospital
🇺🇸Missoula, Montana, United States
Nebraska Heart Hospital
🇺🇸Lincoln, Nebraska, United States
St. Joseph's Hospital Health Center
🇺🇸Syracuse, New York, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
Emory Crawford Long Hospital
🇺🇸Atlanta, Georgia, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
The Heart Center of IN, LLC
🇺🇸Indianapolis, Indiana, United States
Spectrum Health Hospital
🇺🇸Grand Rapids, Michigan, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
EMH Regional Medical Center
🇺🇸Elyria, Ohio, United States
Barnes Jewish Hospital
🇺🇸St. Louis, Missouri, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Jewish Hospital
🇺🇸Louisville, Kentucky, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Sacred Heart Medical Center
🇺🇸Eugene, Oregon, United States
Wake Medical Center
🇺🇸Raleigh, North Carolina, United States
Saint Joseph's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
St. John's Hospital
🇺🇸Springfield, Illinois, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Elmhurst Memorial Hospital
🇺🇸Elmhurst, Illinois, United States
St. Joseph Medical Center
🇺🇸Towson, Maryland, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Pinnacle Health @ Harrisburg Hospital
🇺🇸Harrisburg, Pennsylvania, United States
Baptist Health System - Montclair
🇺🇸Birmingham, Alabama, United States
Arizona Heart Hospital
🇺🇸Phoenix, Arizona, United States
The University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
TexSan Heart Hospital
🇺🇸San Antonio, Texas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
St John Hospital & Medical Center
🇺🇸Detroit, Michigan, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Integris Baptist Medical, Inc.
🇺🇸Oklahoma City, Oklahoma, United States
Baptist Medical Center Princeton
🇺🇸Birmingham, Alabama, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
Alta Bates Summit Medical Center
🇺🇸Oakland, California, United States
Holy Cross Medical Center (prev. North Ridge MC)
🇺🇸Fort Lauderdale, Florida, United States
Poudre Valley Hospital
🇺🇸Fort Collins, Colorado, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Hackensack Medical Center
🇺🇸Hackensack, New Jersey, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States
Methodist Hospital
🇺🇸Houston, Texas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States