Clinical trial NCT01171820: SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
Official title: SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Keywords: drug eluting stents
stents
Angioplasty
coronary artery disease
total coronary occlusion
coronary artery restenosis
stent thrombosis
vascular disease
myocardial ischemia
coronary artery stenosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-07-29
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).

Detailed description: The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic sub-study and the Registry.

The SPIRIT V Diabetic sub-study is a prospective, randomized, active-controlled, single blind, parallel two-arm multi-center study comparing the XIENCE V® EECSS to the TAXUS® Liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. Approximately 300 patients will be randomized (2:1) against the TAXUS® Liberté™ coronary stent system. These patients will be recruited in up to 40 selected sites.

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Diabetic study after 1 year.

Eligibility criteria: Inclusion Criteria:

* at least 18 years
* able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
* diagnosed with diabetes, as documented by medical history.
* evidence of myocardial ischemia
* acceptable candidate for coronary artery bypass grafting (CABG) surgery
* agree to undergo all clinical investigation plan (CIP)-required follow-up examinations
* artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents
* maximum of one, de novo, target lesion per native major epicardial vessel or side branch
* target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
* target lesion ≤ 28 mm in length by visual estimate
* target lesion must be in a major artery or branch with a visually estimated stenosis of \> 50% and \< 100% and a TIMI flow \> 1

Exclusion Criteria:

* known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure
* current unstable arrhythmias
* Left ventricular ejection fraction \< 30%
* received a heart or any other organ transplant or is on a waiting list for any organ transplant
* receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
* receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease
* known hypersensitivity or contraindication to specific agents
* elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel
* platelet count limits, white blood cell limits or documented or suspected liver disease
* renal insufficiency
* history of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Cerebrovascular accident or transient ischemic attack within the past 6 months
* significant GI or urinary bleed within the past 6 months
* history of other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the CIP, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)

Target lesion meets any of the following criteria:

* In-stent restenotic
* aorto-ostial location (within 3 mm)
* left main location
* located within 2 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX)
* located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft (defined as vessel irregularity per angiogram and \> 20% stenosed lesion by visual estimation)
* lesion involving a side branch ≥ 2.5 mm in diameter
* lesion involving a side branch with \> 50% stenosis by visual estimation Lesion involving a side branch requiring predilatation
* located in a major epicardial vessel that has been previously treated with brachytherapy
* located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy), \< 9 months prior to the index procedure
* total occlusion (TIMI flow 0), prior to wire crossing
* excessive tortuosity proximal to or within the lesion
* extreme angulation (≥ 90%) proximal to or within the lesion
* heavy calcification

The target vessel contains visible thrombus

Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy)

Patient has additional clinically significant lesion(s) (\> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required

Primary outcomes:
measure: In-stent Late Loss (LL)
timeFrame: 270 days
Secondary outcomes:
measure: Clinical Device Success (Per-lesion)
timeFrame: immediately post-procedure
measure: Clinical Procedure Success (Per-patient)
timeFrame: immediately post-procedure
measure: In-segment Late Loss
timeFrame: 270 days
measure: Proximal Late Loss
timeFrame: 270 day
measure: Distal Late Loss
timeFrame: 270 days
measure: In-stent Angiographic Binary Restenosis Rate
timeFrame: 270 days
measure: In-segment Angiographic Binary Restenosis Rate
timeFrame: 270 days
measure: In-stent Percent Diameter Stenosis (% DS)
timeFrame: 270 days
measure: In-segment Percent Diameter Stenosis (% DS)
timeFrame: 270 days
measure: Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)
timeFrame: 0 to 37 days
measure: Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)
timeFrame: 254 days
measure: Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)
timeFrame: 365 days
measure: Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.
timeFrame: 37 days
measure: Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.
timeFrame: 254 days
measure: Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.
timeFrame: 393 days
measure: Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)
timeFrame: 37 days
measure: Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)
timeFrame: 254 days
measure: Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)
timeFrame: 393 days
measure: Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)
timeFrame: 37 days
measure: Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)
timeFrame: 254 days
measure: Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)
timeFrame: 393 days
measure: Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR)
timeFrame: 37 days
measure: Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)
timeFrame: 254 days
measure: Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)
timeFrame: 393 days
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken
city: Grenoble
country: France
facility: C.H.U. - Hopital Michallon
city: Lille
country: France
facility: CHU Lille - Hôpital Cardiologique
city: Bernau
country: Germany
facility: Herzzentrum
city: Heidelberg
country: Germany
facility: Universitätsklinikum
city: Neuss
country: Germany
facility: Lukas Krankenhaus Neuss
city: Siegburg
country: Germany
facility: Herzzentrum Siegburg GmbH
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Riuniti
city: Mirano
country: Italy
facility: Ospedale Civile
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Salerno
country: Italy
facility: Azienda Ospedaliera S. Gdi Dio Salerno
city: Kuala Lumpur
country: Malaysia
facility: Institute Jantung Negara
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Bydgoszcz
country: Poland
facility: Medical University of Bydgoszcz
city: Alicante
country: Spain
facility: General De Alicante
city: Barcelona
country: Spain
facility: Hospital Belvigte de Barcelona
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
city: Madrid
country: Spain
facility: Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: La Paz
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: Southampton
country: United Kingdom
facility: Wessex Cardiac Unit
Study officials:
affiliation: International Heart Center Rhein-Ruhr, Essen, Germany
name: Eberhard Grube, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fortis Hospital, New Delhi, India
name: Upendra Kaul, MD
role: PRINCIPAL_INVESTIGATOR
References: