Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180479
Status:
COMPLETED
Last Update Posted:
2011-11-23
First Post:
2005-09-13
Brief Title:
SPIRIT III Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System EECSS
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25 30 35 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 225 mm non-randomized arm using 225 mm diameter XIENCE V Everolimus Eluting CSS
3 US 40 mm non-randomized arm using 40 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 25 30 35 40 mm diameter stents in Japan
The TAXUS EXPRESS2 Paclitaxel Eluting Coronary Stent System is Manufactured by Boston Scientific
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 25 30 35 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 225 mm non-randomized arm using 225 mm diameter XIENCE V Everolimus Eluting CSS
3 US 40 mm non-randomized arm using 40 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 25 30 35 40 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 1002 subjects 21 randomization XIENCE V EECS TAXUS EXPRESS2 PECS with a maximum of two de novo native coronary artery lesion treatment within vessel sizes 25 mm and 375 mm
The SPIRIT III clinical trial also consists of three concurrent US non-randomized arms 225 mm diameter stent 40 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 225 mm and 25 mm and lesion length 22 mm will be enrolled concurrently in the US 225 mm non-randomized treatment arm
2 80 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes 375 mm and 425 mm and lesion length 28 mm will be enrolled concurrently in the US 40 mm non-randomized treatment arm
3 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes 30 mm and 425 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 25 mm and 425 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 inclusionexclusion 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 andor an intravascular ultrasound IVUS follow-up at 240 days as follows
Group A Angiographic and IVUS follow-up at 240 days N240 Group B Angiographic follow-up at 240 days N324 Group C No angiographic or IVUS follow-up N438
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 N105 for 225 mm arm N80 for 40 mm arm and N105 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 N88 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 25 mm and 375 mm 25 mm 30 mm and 35 mm stents Combined data of the US trialJapanese non-randomized arm will be submitted to the Japanese Ministry of Health Labor and Welfare MHLW for Japanese approval for RVD25 mm and 425 mm 25 mm 30 mm 35 mm and 40 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 225 mm diameter stent RVD 225 mm and 25 mm 40 mm diameter stent RVD 375 mm and 425 mm and 38 mm length stent RVD 30 mm and 425 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 vessellesion treatment and up to 20 subjects with dual vessellesion treatment respectively In Japan a minimum of 10 subjects with single vessellesion treatment and up to 20 subjects with dual vessellesion treatment will have a PK measurements performed These subsets will include subjects receiving overlapping stents
The SPIRIT III clinical trial consists of a randomized clinical trial RCT in the US which will enroll approximately 1002 subjects 21 randomization XIENCE V EECS TAXUS EXPRESS2 PECS with a maximum of two de novo native coronary artery lesion treatment within vessel sizes 25 mm and 375 mm
The SPIRIT III clinical trial also consists of three concurrent US non-randomized arms 225 mm diameter stent 40 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 225 mm and 25 mm and lesion length 22 mm will be enrolled concurrently in the US 225 mm non-randomized treatment arm
2 80 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes 375 mm and 425 mm and lesion length 28 mm will be enrolled concurrently in the US 40 mm non-randomized treatment arm
3 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes 30 mm and 425 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 25 mm and 425 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 inclusionexclusion 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 andor an intravascular ultrasound IVUS follow-up at 240 days as follows
Group A Angiographic and IVUS follow-up at 240 days N240 Group B Angiographic follow-up at 240 days N324 Group C No angiographic or IVUS follow-up N438
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 N105 for 225 mm arm N80 for 40 mm arm and N105 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 N88 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 25 mm and 375 mm 25 mm 30 mm and 35 mm stents Combined data of the US trialJapanese non-randomized arm will be submitted to the Japanese Ministry of Health Labor and Welfare MHLW for Japanese approval for RVD25 mm and 425 mm 25 mm 30 mm 35 mm and 40 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 225 mm diameter stent RVD 225 mm and 25 mm 40 mm diameter stent RVD 375 mm and 425 mm and 38 mm length stent RVD 30 mm and 425 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 vessellesion treatment and up to 20 subjects with dual vessellesion treatment respectively In Japan a minimum of 10 subjects with single vessellesion treatment and up to 20 subjects with dual vessellesion treatment will have a PK measurements performed These subsets will include subjects receiving overlapping stents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None