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SPIRIT XLV PAS is a prospective, single arm, multi-center, US and OUS post-approval observational study to evaluate the continued safety and effectiveness of the XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS) Large Vessel (LV) sizes (diameter 4.5 mm and 5.0 mm) during commercial use in a real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System | Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS) | Device | XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system. |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive Primary Endpoint: Target Lesion Failure (TLF) | TLF is defined as the composite of cardiac death, myocardial infarction related to the target vessel (TV-MI), or ischemic driven target lesion revascularization (ID-TLR). | At 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLFsp-MI) and Target Lesion Failure (TLFSCAI) | TLFsp-MI is defined as the composite of CD and TV-MI, including spontaneous MI and excluding periprocedural MI and, or ID-TLR. TLFSCAI is defined as the composite of CD and TV-MI, including both periprocedural MI and spontaneous MI, or ID-TLR. | 1 year |
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Inclusion Criteria:
General Inclusion Criteria
Subject must be at least 18 years of age.
Subject or a legally authorized representative must provide written informed consent per site requirements.
Subject must have evidence of myocardial ischemia (STEMI, NSTEMI, Unstable Angina or Stable Angina) or who have silent ischemia with evidence of ischemia, appropriate for PCI treatment with DES. Subject with stable angina or silent ischemia must have objective sign of ischemia as suggested by one of the following:
Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.
Angiographic Inclusion Criteria
Patients who have lesion(s) in a vessel with reference vessel diameter > 4.25 mm and ≤ 5.25 mm as the target lesion
Patients who receive at least one Skypoint LV stent
Exclusion Criteria:
General Exclusion Criteria
Angiographic Exclusion Criteria:
Patients who require three vessel treatment.
If left main coronary artery (LMCA) is the intended target vessel, patients who have unprotected left main disease with the SYNTAX Score ≥ 23
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Subjects of all genders from the general population who have at least one XIENCE Skypoint LV implanted.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States | ||
| Memorial Hospital Jacksonville |
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The study registered a total of 102 subjects at 18 investigational sites on September 14, 2022 to November 8, 2023. and all active subjects enrolled completed their 12-month follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System | Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included. XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS): XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2023 | Oct 6, 2025 |
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|
| Jacksonville |
| Florida |
| 32216 |
| United States |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | United States |
| Via Christi Regional Medical Center - St. Francis Campus | Wichita | Kansas | 67226 | United States |
| Bryan Heart | Lincoln | Nebraska | 68506 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| Pinnacle Health System | Wormleysburg | Pennsylvania | 17043 | United States |
| Anmed Health | Anderson | South Carolina | 29621 | United States |
| Greenville Health System | Greenville | South Carolina | 29605-5601 | United States |
| Hendrick Medical Center | Abilene | Texas | 79601 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75074 | United States |
| Shannon Clinic | San Angelo | Texas | 76903 | United States |
| Clinique Pasteur Toulouse | Toulouse | Midi-Pyrenees | 31300 | France |
| Hopital Cardiovasculaire et Pneumologique Louis Pradel | Lyon | Rhone | France |
| Hospital Clinico San Carlos | Madrid | Madrid | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain |
| Hospital Virgen de Rocio | Seville | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System | Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included. XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS): XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Subjects may have more than one race reported. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Hyperlipidemia | Count of Participants | Participants |
| |||||||||||||||||||||||
| Hypertension | Count of Participants | Participants |
| |||||||||||||||||||||||
| Tobacco use | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Descriptive Primary Endpoint: Target Lesion Failure (TLF) | TLF is defined as the composite of cardiac death, myocardial infarction related to the target vessel (TV-MI), or ischemic driven target lesion revascularization (ID-TLR). | Analysis population included subjects who provided written informed consent, have at least one XIENCE Skypoint stent diameters 4.5 mm and 5.0 mm implanted, and were confirmed to meet all general/angiographic eligibility criteria at registration. | Posted | Number | 95% Confidence Interval | percentage of participants | At 1 Year |
|
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| |||||||||||||||||||||||||
| Secondary | Target Lesion Failure (TLFsp-MI) and Target Lesion Failure (TLFSCAI) | TLFsp-MI is defined as the composite of CD and TV-MI, including spontaneous MI and excluding periprocedural MI and, or ID-TLR. TLFSCAI is defined as the composite of CD and TV-MI, including both periprocedural MI and spontaneous MI, or ID-TLR. | Analysis population included subjects who provided written informed consent, have at least one XIENCE Skypoint stent diameters 4.5 mm and 5.0 mm implanted, and were confirmed to meet all general/angiographic eligibility criteria at registration. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
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1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System | Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included. XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS): XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system. | 5 | 102 | 35 | 102 | 80 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Mitral valve incompetence | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Sinus arrest | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (27.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Duodenal stenosis | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Oesophageal stenosis | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Death | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Perforation | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Vascular stent thrombosis | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA (27.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
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| Myocardial necrosis marker increased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
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| Intracranial aneurysm | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
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| Ureteric obstruction | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
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| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Arterial revascularisation | Surgical and medical procedures | MedDRA (27.1) | Systematic Assessment |
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| Ligament operation | Surgical and medical procedures | MedDRA (27.1) | Systematic Assessment |
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| Aortic stenosis | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Peripheral artery stenosis | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Peripheral vascular disorder | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Coronary artery dissection | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
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| Myocardial necrosis marker increased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
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| Breast mass | Reproductive system and breast disorders | MedDRA (27.1) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Arterial revascularisation | Surgical and medical procedures | MedDRA (27.1) | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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Inst. may publish data/results individually from its site after any of (1) a multi-center publication is published, (2) no multicenter publication is submitted within 18monthsafter closure of the Study, or (3) Abbott confirms there will be no multi-center publication. Inst. shall provide Sponsor with draft at least 60 days prior to submission for Sponsor review/comment. Upon request, Publication shall be delayed an additional 60 days. Due consideration will be given to Sponsor comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vinuta Rau | Abbott | + 1 408-834-0621 | vinuta.rau@abbott.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Unknown or Not Reported |
|
| Black or African American |
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| Native Hawaiian or Pacific Islander |
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| Caucasian |
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| Declined or unable to disclose due to local regulation |
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| More than one race |
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