ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
SPIRIT III Clinical Trial of the XIENCE™ V Everolimus Eluting Coronary Stent System (EECSS)

This study is ongoing, but not recruiting participants.
Information provided by Abbott Vascular

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  SPIRIT III Clinical Trial of the XIENCE™ V Everolimus Eluting Coronary Stent System (EECSS)
Official Title  SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
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

CAUTION: XIENCE™ V Everolimus Eluting Coronary Stent System is an Investigational device. Limited by Federal (U.S.) law to investigational use only.

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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Primary Endpoint: In-segment late loss (LL) [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
Major Secondary Endpoint: Ischemia driven target vessel failure (TVF) [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Target vessel failure (TVF) [ Time Frame: at 30, 180 days, and 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]
Ischemia driven target lesion revascularization (TLR) [ Time Frame: at 30, 180 and 270 days, and 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]
Ischemia driven target vessel revascularization (TVR) [ Time Frame: at 30, 180 and 270 days and 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]
Ischemia driven major adverse cardiac event (MACE) [ Time Frame: at 30, 180 and 270 days and 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]
Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
Acute success (clinical device and clinical procedure) [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
Proximal and distal LL [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
In-stent LL [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
In-stent and in-segment % angiographic binary restenosis (% ABR) rate [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
In-stent and in-segment % diameter stenosis (% DS) [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
In-stent % volume obstruction (% VO) [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
Condition  Stents
Coronary Artery Disease
Total Coronary Occlusion
Coronary Artery Restenosis
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Intervention  Device: XIENCE™ V Everolimus Eluting Coronary Stent
Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
MEDLINE PMIDs 18430909
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  1002
Start Date  June 2005
Completion Date December 2011
Eligibility Criteria 

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00180479
Organization ID 03-360
Secondary IDs ††
Study Sponsor  Abbott Vascular
Collaborators ††
Investigators 
Principal Investigator:     Gregg W Stone, MD     Columbia University Medical Center    
Information Provided By Abbott Vascular
Verification Date June 2008
First Received Date  September 13, 2005
Last Updated Date June 6, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers