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The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB III RCT (NCT01751906). The objective is to determine the pharmacokinetics of everolimus delivered by the Absorb BVS in a separate and non-randomized cohort of subjects who only receive Absorb BVS with a maximum of two de novo native coronary artery lesions after implantation of the Absorb BVS.
Note: The ABSORB III PK subjects will not contribute to the determination of the ABSORB III RCT primary endpoint.
To ensure the PK measurements reflect everolimus exposure due to Absorb BVS only, the PK sub-study will not allow non-target lesion treatment.
Blood Sampling Timing:
Pre-Absorb BVS implantation: Baseline
o Baseline is defined as prior to implantation of the first Absorb BVS; the blood sample will be drawn on the day of the index procedure either through a heparin lock, venous sheath, or venipuncture.
Post-Absorb BVS implantation: 10 and 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 24 hrs (1 day), 48 hrs (2 days), 72 hrs (3 days), 96 hrs (4 days), 120 hrs (5 days), 168 hrs (7 days), 336 hrs (14 days), and 720 hrs (30 days).
Pharmacokinetic (PK) parameters will include time to maximum concentration (tmax); maximum concentration (Cmax); AUC24h: Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS; AUClast: Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration; AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time; terminal elimination rate constant (λz); terminal elimination half-life (t1/2term); drug clearance (CL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary artery stenting: Absorb BVS | Experimental | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary artery stenting: Absorb BVS | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) | Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). | 0 to 30 days |
| Time of Maximum (Tmax) | Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). | 0 to 30 days |
| AUC24h | Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method. | 0 to 24 hours |
| AUC Last | Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method. | 0 to 30 days |
| AUC 0-infinity | AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: AUC0-∞ = AUClast + (Clast/λz) The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as: %AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ * 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR). | 0 to 1853 Days |
| Number of Participants With All Death |
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General Inclusion Criteria:
Angiographic Inclusion Criteria:
One or two de novo target lesions:
Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed % diameter stenosis (DS) of ≥ 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve (FFR), stress test), unstable angina or post-infarct angina.
General Exclusion Criteria:
Any surgery requiring general anesthesia or discontinuation of aspirin and/or an Adenosine diphosphate receptor (ADP) antagonist is planned within 12 months after the procedure.
Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
Subject had an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band isoenzyme (CK-MB) have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.
Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
Subject has a cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:
Subject has a left ventricular ejection fraction (LVEF) < 30%
Subject has undergone prior percutaneous coronary intervention (PCI) within the target vessel(s) during the last 12 months.
Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure.
Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
At the time of screening, the subject has a malignancy that is not in remission.
Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).
Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.
Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.
Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.).
Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.
Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause.
Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
Subject is part of a vulnerable population
Angiographic Exclusion Criteria:
All exclusion criteria apply to the target lesion(s) or target vessel(s).
Lesion which prevents successful balloon pre-dilatation
Lesion is located in left main.
Aorto-ostial RCA lesion.
Lesion located within 3 mm of the origin of the LAD or LCX.
Lesion involving a bifurcation with a:
Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS.
Vessel contains thrombus as indicated in the angiographic images or by intravascular ultrasound (IVUS) or optical coherence tomography (OCT).
Lesion or vessel involves a myocardial bridge.
Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS would need to cross the stent to reach the target lesion.
Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.
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| Name | Affiliation | Role |
|---|---|---|
| David G. Rizik, MD | Scottsdale Healthcare, Scottsdale, AZ | Principal Investigator |
| Louis A. Cannon, MD | Cardiac and Vascular Research Center of Northern Michigan Petoskey, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Healthcare | Scottsdale | Arizona | 85258 | United States | ||
| Cardiac & Vascular Research Center of Northern Michigan |
In this sub-study, subjects received either one (N=8) or two (N=4) Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
The first subject was enrolled on June 2, 2014 and the last subject was enrolled on September 17, 2014. The last 30-day follow-up visit occurred on October 14, 2014. Database was locked on Oct 29, 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Coronary Artery Stenting: Absorb BVS | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm • Scaffold lengths: 8, 12, 18, and 28 mm |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The PK sub-study had slightly more male subjects, and slightly more subjects with dyslipidemia and hypertension requiring medication and subjects with stable angina as compared to ABSORB III Primary Analysis Group. The PK sub-study had fewer subjects who had undergone prior coronary intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Coronary Artery Stenting: Absorb BVS | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm • Scaffold lengths: 8, 12, 18, and 28 mm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maximum Concentration (Cmax) | Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Median | Full Range | nanograms per milliliter | 0 to 30 days |
|
5 years
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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 | Coronary Artery Stenting: Absorb BVS | Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm • Scaffold lengths: 8, 12, 18, and 28 mm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Latania Chura | Abbott Vascular | 503-935-3002 | latania.chura@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2018 | Nov 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| D003327 | Coronary Disease |
| D023903 | Coronary Restenosis |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| 0 to 30 days |
| Terminal Elimination Rate Constant (λz) | The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve. | 0 to 30 days |
| Terminal Elimination Half-life (t1/2term) | The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: t1/2term = 0.693/λz. | 0 to 30 days |
| Drug Clearance (CL) | The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated as: CL = Dose/AUC0 - ∞ . | 0 to 30 days |
All death includes cardiac death, vascular death, and non-cardiac death.
| 0 to 1853 Days |
| Number of Participants With All Myocardial Infarction (MI) | All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI). | 0 to 1853 Days |
| Number of Participants With All Target Lesion Revascularization (TLR) | All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR). | 0 to 1853 Days |
| Number of Participants With All Target Vessel Revascularization (TVR) | All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR). | 0 to 1853 Days |
| Number of Participants With All Revascularization | All revascularization includes ischemia driven revascularization and non ischemia driven revascularization. | 0 to 1853 Days |
| Number of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable) | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation | ≤ 1 day |
| Number of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable) | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation | >1 to 30 days |
| Number of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable) | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation | 31 to 393 days |
| Number of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable) | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation | 0 to 1853 Days |
| Petoskey |
| Michigan |
| 49770 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hypertension Requiring Medication | Count of Participants | Participants |
|
| Dyslipidemia Requiring Medication | Count of Participants | Participants |
|
| Prior Coronary Intervention | Count of Participants | Participants |
|
| Stable Angina | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Time of Maximum (Tmax) | Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Median | Full Range | Hours | 0 to 30 days |
|
|
|
| Primary | AUC24h | Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method. | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Median | Full Range | ng*h/mL | 0 to 24 hours |
|
|
|
| Primary | AUC Last | Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method. | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Median | Full Range | ng*h/mL | 0 to 30 days |
|
|
|
| Primary | AUC 0-infinity | AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: AUC0-∞ = AUClast + (Clast/λz) The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as: %AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ * 100 | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Median | Full Range | ng*h/mL | 0 to 30 days |
|
|
|
| Primary | Terminal Elimination Rate Constant (λz) | The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve. | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Median | Full Range | 1/hour | 0 to 30 days |
|
|
|
| Primary | Terminal Elimination Half-life (t1/2term) | The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: t1/2term = 0.693/λz. | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Median | Full Range | Hours | 0 to 30 days |
|
|
|
| Primary | Drug Clearance (CL) | The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated as: CL = Dose/AUC0 - ∞ . | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Median | Full Range | Liter/hour | 0 to 30 days |
|
|
|
| Secondary | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR). | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Count of Participants | Participants | 0 to 1853 Days |
|
|
|
| Secondary | Number of Participants With All Death | All death includes cardiac death, vascular death, and non-cardiac death. | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Count of Participants | Participants | 0 to 1853 Days |
|
|
|
| Secondary | Number of Participants With All Myocardial Infarction (MI) | All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI). | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Count of Participants | Participants | 0 to 1853 Days |
|
|
|
| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR). | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Count of Participants | Participants | 0 to 1853 Days |
|
|
|
| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR). | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Count of Participants | Participants | 0 to 1853 Days |
|
|
|
| Secondary | Number of Participants With All Revascularization | All revascularization includes ischemia driven revascularization and non ischemia driven revascularization. | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Count of Participants | Participants | 0 to 1853 Days |
|
|
|
| Secondary | Number of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable) | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Count of Participants | Participants | ≤ 1 day |
|
|
|
| Secondary | Number of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable) | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Count of Participants | Participants | >1 to 30 days |
|
|
|
| Secondary | Number of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable) | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Count of Participants | Participants | 31 to 393 days |
|
|
|
| Secondary | Number of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable) | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation | ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. | Posted | Count of Participants | Participants | 0 to 1853 Days |
|
|
|
| 2 |
| 12 |
| 10 |
| 12 |
| 12 |
| 12 |
| ANGINA PECTORIS AGGRAVATED | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| ARRHYTHMIA | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| ATRIAL FIBRILLATION AGGRAVATED | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| NON STEMI | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| STABLE ANGINA PECTORIS | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| UNSTABLE ANGINA | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| SMALL BOWEL OBSTRUCTION | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| UPPER GASTROINTESTINAL BLEEDING | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHEST PAIN (NON-CARDIAC) | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| CELLULITIS OF LEG | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| CORONARY ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| IN-STENT CORONARY ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| PAINFULL ARM | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| SPINAL STENOSIS OF LUMBAR REGION | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| ACUTE ON CHRONIC RENAL FAILURE | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| ACUTE RENAL FAILURE | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| BENIGN PROSTATIC HYPERTROPHY | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| PULMONARY EDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| POPLITEAL VEIN THROMBOSIS | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| ANGINA PECTORIS AGGRAVATED | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| ARRHYTHMIA | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| ATRIAL FIBRILLATION AGGRAVATED | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| BRADYCARDIA | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHEST PAIN - CARDIAC | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| CONGESTIVE HEART FAILURE | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| CORONARY ARTERY DISSECTION | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| CORONARY NO-REFLOW PHENOMENON | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| NON STEMI | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| STABLE ANGINA PECTORIS | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| UNSTABLE ANGINA | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| HEARTBURN | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| SMALL BOWEL OBSTRUCTION | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| UPPER GASTROINTESTINAL BLEEDING | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHEST PAIN (NON-CARDIAC) | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| INFUSION SITE HEMATOMA | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| CELLULITIS OF LEG | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| BRUISE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| CORONARY ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| IN-STENT CORONARY ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| POST PROCEDURAL MYOCARDIAL INFARCTION | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| POSTOPERATIVE HYPOTENSION | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| TICK BITE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| URINARY RETENTION POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| CARDIAC ENZYMES INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| CREATINE KINASE MB INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| BACK PAIN AGGRAVATED | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| COSTOCHONDRITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| MONOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| PAINFUL L ARM | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| SPINAL STENOSIS OF LUMBAR REGION | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| SCIATICA | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| ACUTE ON CHRONIC RENAL FAILURE | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| ACUTE RENAL FAILURE | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| BENIGN PROSTATIC HYPERTROPHY | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| OBSTRUCTIVE SLEEP APNEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| PULMONARY EDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| SHORTNESS OF BREATH | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| POPLITEAL VEIN THROMBOSIS | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| SLOW REFLOW PHENOMENON | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
Principal Investigators shall not present or publish, nor submit for publication, any work resulting from the Services without Sponsor's prior written approval.
Except as specifically set forth herein, neither party shall use the other party's name or trademark, or the name nor trademark of such other party's affiliate, in any publicity, advertising or announcement, or disclose the existence or terms of this Agreement, without the consenting party's prior written approval.
| D014652 |
| Vascular Diseases |