Coronary Artery Disease Clinical Trial
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
Verified date | October 2010 |
Source | Abbott Vascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 324 |
Est. completion date | July 2010 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 CABG surgery - agree to undergo all 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 AMI within 72 hours preceding the index procedure - current unstable arrhythmias - LVEF < 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, WBC limits or documented or suspected liver disease - renal insufficiency - history of bleeding diathesis or coagulopathy or will refuse blood transfusions - CVA or TIA 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 LAD or 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Salzburger Landeskliniken | Salzburg | |
France | C.H.U. - Hopital Michallon | Grenoble | |
France | CHU Lille - Hôpital Cardiologique | Lille | |
Germany | Herzzentrum | Bernau | |
Germany | Universitätsklinikum | Heidelberg | |
Germany | Lukas Krankenhaus Neuss | Neuss | |
Germany | Herzzentrum Siegburg GmbH | Siegburg | |
Israel | Sheba Medical Center | Ramat Gan | |
Italy | Azienda Ospedaliera Riuniti | Bergamo | |
Italy | Ospedale Civile | Mirano | |
Italy | Azienda Ospedaliera di Padova | Padova | |
Italy | IRCCS Policlinico San Matteo | Pavia | |
Italy | Azienda Ospedaliera S. Gdi Dio Salerno | Salerno | |
Malaysia | Institute Jantung Negara | Kuala Lumpur | |
Netherlands | Medisch Centrum Alkmaar | Alkmaar | |
Netherlands | Maasstad Ziekenhuis | Rotterdam | |
Poland | Medical University of Bydgoszcz | Bydgoszcz | |
Spain | General De Alicante | Alicante | |
Spain | Hospital Belvigte de Barcelona | Barcelona | |
Spain | Hospital Santa Creu I Sant Pau | Barcelona | |
Spain | Clinico San Carlos | Madrid | |
Spain | Hospital Puerta de Hierro | Madrid | |
Spain | La Paz | Madrid | |
Spain | Hospital Virgen de la Arrixaca | Murcia | |
Spain | Hospital General de Valencia | Valencia | |
Thailand | King Chulalongkorn Memorial Hospital | Bangkok | |
United Kingdom | King's College Hospital | London | |
United Kingdom | Wessex Cardiac Unit | Southampton |
Lead Sponsor | Collaborator |
---|---|
Abbott Vascular |
Austria, France, Germany, Israel, Italy, Malaysia, Netherlands, Poland, Spain, Thailand, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In-stent Late Loss(LL) | In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up | 270 days | No |
Secondary | Clinical Device Success | Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy. | Acute: At time of index procedure | No |
Secondary | Clinical Procedure Success | Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success. | Acute: At time of index procedure | Yes |
Secondary | In-segment Late Loss | In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up | 270 days | No |
Secondary | Proximal Late Loss | Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up | 270 day | No |
Secondary | Distal Late Loss | Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up | 270 days | No |
Secondary | In-stent Angiographic Binary Restenosis Rate | Percent of patients with a follow-up percent diameter stenosis of = 50% per Quantitative Coronary Angiogram. | 270 days | No |
Secondary | In-segment Angiographic Binary Restenosis Rate | Percent of patients with a follow-up percent diameter stenosis of = 50% per Quantitative Coronary Angiogram. | 270 days | No |
Secondary | In-stent Percent Diameter Stenosis | This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiogram. |
270 days | No |
Secondary | In-segment Percent Diameter Stenosis | This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiogram. |
270 days | No |
Secondary | Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) | A thrombosis is blood clot that forms on the stent. This outcome measures the percentage of participants found to have this condition. | 30 days | Yes |
Secondary | Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) | A thrombosis is blood clot that forms on the stent | 240 days | Yes |
Secondary | Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) | A thrombosis is blood clot that forms on the stent | 1 year | Yes |
Secondary | Adjudicated Revascularizations (TLR/TVR/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. | 30 days | Yes | |
Secondary | Adjudicated Revascularizations (TLR/TVR/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. | 240 days | Yes | |
Secondary | Adjudicated Revascularizations (TLR/TVR/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. | 1 year | Yes | |
Secondary | Adjudicated Composite Rate of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) | 30 days | Yes | |
Secondary | Adjudicated Composite Rate of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) | 240 days | Yes | |
Secondary | Adjudicated Composite Rate of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) | 1 year | Yes | |
Secondary | Adjudicated Composite Rate of All Death, MI and Target Vessel Revascularization (TVR) | 30 days | Yes | |
Secondary | Adjudicated Composite Rate of All Death, MI and Target Vessel Revascularization (TVR) | 240 days | Yes | |
Secondary | Adjudicated Composite Rate of All Death, MI and Target Vessel Revascularization (TVR) | 1 year | Yes | |
Secondary | Adjudicated Composite Rate of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) | 30 days | Yes | |
Secondary | Adjudicated Composite Rate of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) | 240 days | Yes | |
Secondary | Adjudicated Composite Rate of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) | 1 year | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |