Coronary Artery DiseaseENDEAVOR PKNCT00314275
The ENDEAVOR Pharmacokinetic (PK) Registry: The Medtronic Endeavor Drug Eluting Coronary Stent System
A study testing Coronary Artery Stenting and Endeavor in people with Coronary Artery Disease, run by Medtronic Vascular at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety associated with ABT-578 administered using the Medtronic Endeavor Drug Eluting Coronary Stent system in the treatment of single de novo lesions in native coronary arteries between 2.5 - 3.5 mm in diameter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary Artery Stenting and Endeavor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is at least 18 years of age.
- The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study.
- The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery.
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
- The patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.
Who cannot join
- A known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine or clopidogrel, cobalt, nickel, chromium, molybdenum, polymer coatings, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- History of an allergic reaction or significant sensitivity to drugs similar to ABT-578, rapamycin, tacrolimus, everolimus, or any other analog or derivative.
- A platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³.
- A creatinine level > 2.0 mg/dL within seven days prior to index procedure. Evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: Q wave or non-Q wave myocardial infarction having creatine kinase [CK] enzymes greater than or equal to 2 X the upper laboratory normal with the presence of a creatine kinase myocardial-band isoenzyme [CK-MB] elevated above the institution's upper limit of normal).
- Previous percutaneous coronary intervention (PCI) of the target vessel within 9 months pre-procedure.
- Planned PCI of any vessel within 30 days post-procedure.
Show all 11Show fewer
- During the index procedure, the target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to: cutting balloon, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.).
- History of a stroke or transient ischemic attack within the prior 6 months. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Concurrent medical condition with a life expectancy of less than 12 months. Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to, brachytherapy.
- Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (IVUS) or other coronary artery imaging procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Santa Rosa Memorial Hospital
Santa Rosa, California, 95405
About this study
Official title: Evaluation of Pharmacokinetics (PK) and Safety of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety associated with ABT-578 administered using the Medtronic Endeavor Drug Eluting Coronary Stent system in the treatment of single de novo lesions in native coronary arteries between 2.5 - 3.5 mm in diameter.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary Artery Stenting, Endeavor
- Keywords
- Pharmacokinetics, Coronary Artery Disease, PCI, Drug Eluting Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Artery StentingDevice
Drug eluting stent
EndeavorDevice
Drug eluting stent
| Study group | Role | What they receive |
|---|---|---|
| ENDEAVOR | Experimental | Drug Eluting Stent Receives: Device: Coronary Artery Stenting; Device: Endeavor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, CL, etc.)
Measured: 9 months
Secondary outcomes (9)
Success (device, lesion, and procedure)
Measured: 9 months
Major adverse cardiac event (MACE) rate
Measured: 30 days, 6, 9 and 12 months
Target site revascularization (TSR), target vessel revascularization (TVR), and target vessel failure (TVF) rate
Measured: 9 months
For patients receiving overlapping stents at the target lesion: angiographic parameters (in-stent and in-segment), including: late lumen loss
Measured: 8 months
Late loss index
Measured: 9 months
Angiographic binary restenosis (ABR) rate
Measured: 9 months
Minimum luminal diameter (MLD)
Measured: 9 months
Percent diameter stenosis (%DS)
Measured: 9 months
Neointimal hyperplastic volume as measured by intravascular ultrasound (IVUS)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startJan 2006
- Primary completionMay 2006
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin B Leon, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314275
- Sponsor's protocol ID
- IP-061
- Acronym
- ENDEAVOR PK
- Status last verified
- Apr 2012
- First submitted
- 11 Apr 2006
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mauri L, Massaro JM, Jiang S, Meredith I, Wijns W, Fajadet J, Kandzari DE, Leon MB, Cutlip DE, Thompson KP. Long-term clinical outcomes with zotarolimus-eluting versus bare-metal coronary stents. JACC Cardiovasc Interv. 2010 Dec;3(12):1240-9. doi: 10.1016/j.jcin.2010.08.021.
PubMed 21232717
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacokinetics (PK) and Safety of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT00314275
- Acronym / sponsor ID
- ENDEAVOR PK / IP-061
- Conditions
- Coronary Artery Disease
- Keywords
- Pharmacokinetics, Coronary Artery Disease, PCI, Drug Eluting Stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- May 2006 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety associated with ABT-578 administered using the Medtronic Endeavor Drug Eluting Coronary Stent system in the treatment of single de novo lesions in native coronary arteries between 2.5 - 3.5 mm in diameter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENDEAVOR | Experimental | Device: Coronary Artery Stenting, Device: EndeavorDrug Eluting Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is at least 18 years of age.
- The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study.
- The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery.
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
- The patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.
Key exclusion criteria (11 listed)
- A known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine or clopidogrel, cobalt, nickel, chromium, molybdenum, polymer coatings, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- History of an allergic reaction or significant sensitivity to drugs similar to ABT-578, rapamycin, tacrolimus, everolimus, or any other analog or derivative.
- A platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³.
- A creatinine level > 2.0 mg/dL within seven days prior to index procedure. Evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: Q wave or non-Q wave myocardial infarction having creatine kinase [CK] enzymes greater than or equal to 2 X the upper laboratory normal with the presence of a creatine kinase myocardial-band isoenzyme [CK-MB] elevated above the institution's upper limit of normal).
- Previous percutaneous coronary intervention (PCI) of the target vessel within 9 months pre-procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Artery StentingDrug eluting stent | Device | ENDEAVOR |
| EndeavorDrug eluting stent | Device | ENDEAVOR |
Primary outcome
Pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, CL, etc.)
Time frame: 9 months
9 secondary outcomes
Success (device, lesion, and procedure)
Time frame: 9 months
Major adverse cardiac event (MACE) rate
Time frame: 30 days, 6, 9 and 12 months
Target site revascularization (TSR), target vessel revascularization (TVR), and target vessel failure (TVF) rate
Time frame: 9 months
For patients receiving overlapping stents at the target lesion: angiographic parameters (in-stent and in-segment), including: late lumen loss
Time frame: 8 months
Late loss index
Time frame: 9 months
Angiographic binary restenosis (ABR) rate
Time frame: 9 months
Minimum luminal diameter (MLD)
Time frame: 9 months
Percent diameter stenosis (%DS)
Time frame: 9 months
Neointimal hyperplastic volume as measured by intravascular ultrasound (IVUS)
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
- Derived from this study: PubMed 21232717Mauri L, Massaro JM, Jiang S, Meredith I, Wijns W, Fajadet J, Kandzari DE, Leon MB, Cutlip DE, Thompson KP. Long-term clinical outcomes with zotarolimus-eluting versus bare-metal coronary stents. JACC Cardiovasc Interv. 2010 Dec;3(12):1240-9. doi: 10.1016/j.jcin.2010.08.021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin B Leon, M.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Artery Stenting and Endeavor in people with Coronary Artery Disease, run by Medtronic Vascular at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, CL, etc.) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00314275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.