Peripheral Vascular DiseaseiCARUSNCT00593385
Atrium iCAST Iliac Stent Pivotal Study
A study testing iCAST covered stent in people with Peripheral Vascular Disease, run by Atrium Medical Corporation at 25 sites in 2 countries.
Trial summary
Prospective, multicenter, non-randomized, single-arm registry to evaluate the safety and effectiveness of the iCAST Covered Stent System in the treatment of patients with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- iCAST covered stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Oct 2007to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject is 18 years of age or older.
- Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4).
- Presence of de novo and/or restenotic lesions in the common and/or external iliac artery.
- Subject has single, bilateral or multiple target lesions that is (are) ≥ 50% stenosed by visual estimate.
- The target lesion(s) can be successfully crossed with a guide wire and dilated.
- The target segment of subject's lesion(s) is between 5 and 12mm in diameter and less than 110 mm in length.
Show all 10Show fewer
- Subject has angiographic evidence of a patent profunda or superficial femoral artery (SFA) in the target limb.
- Subject has provided written informed consent.
- Subject is able and willing to adhere to the required follow-up visits and testing through month 36.
- Subject is able and willing to adhere to the required follow-up medication regimen.
Who cannot join
- Presence of other non-target ipsilateral arterial lesions requiring treatment within 30 days post-procedure (Note that treatment of ipsilateral SFA lesions may be allowed under certain circumstances). Treatment of lesions in any other vascular bed must be completed at least 30 days prior to enrollment.
- The target lesion(s) has adjacent, acute thrombus.
- The target lesion(s) is highly calcified or was previously treated with a stent.
- Target lesion involves the internal iliac artery resulting in crossing of the side-branch with the iCAST device (e.g. "jailing" of the side-branch).
- Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion.
- Subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery prior to initiation of the iCAST implant procedure.
Show all 20Show fewer
- Subject has a post-surgical stenosis and anastomotic suture treatments of the target vessel.
- Subject has a vascular graft previously implanted in the native iliac vessel.
- Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
- Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has a hypersensitivity to stainless steel, expanded polytetrafluoroethylene (ePTFE) or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
- History of neutropenia (WBC <3,000/mm3), coagulopathy, or thrombocytopenia (platelet count <80,000/ μL) that has not resolved or has required treatment in the past 6 months.
- Known bleeding or hypercoagulability disorder or significant anemia (Hb< 8.0) that cannot be corrected.
- Subject has the following laboratory values:
- platelet count less than 80,000/ μL,
- prothrombin time (PT)/partial thromboplastin time (PTT) not within normal limits
- serum creatinine level greater than 2.5 mg/dL
- Subject requires general anesthesia for the procedure.
- Subject is pregnant.
- Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
- Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. Note: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States24 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Piedmont Hospital Research Institute
Atlanta, Georgia, 30309
Mass General Hospital
Boston, Massachusetts, 02114
Holy Spirit Cardiovascular Institute
Camp Hill, Pennsylvania, 17011
Northwestern University
Chicago, Illinois, 60611
Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
University Hospitals, Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
MidWest Cardiology Research Foundation
Columbus, Ohio, 43214
Cardiovascular Research Institute of Dallas
Dallas, Texas, 75231
Duke University Medical Center
Durham, North Carolina, 27710
Forest General Hospital
Hattiesburg, Mississippi, 39401
Terrebonne General Medical Center
Houma, Louisiana, 70360
The Methodist Hospital
Houston, Texas, 77030
Krannert Institute of Cardiology
Indianapolis, Indiana, 46202
Kansas City Heart Foundation
Kansas City, Missouri, 64132
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, 37934
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Louisville
Louisville, Kentucky, 40202
Fogarty Clincal Research Incorporated
Mountain View, California, 94040
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
University of California, Davis
Sacramento, California, 95817
North Central Heart Institute
Sioux Falls, South Dakota, 57108
About this study
Prospective, multicenter, non-randomized, single-arm registry to evaluate the safety and effectiveness of the iCAST Covered Stent System in the treatment of patients with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.
Read the detailed description
STUDY DESIGN: Prospective, multicenter, non-randomized, single-arm registry
OBJECTIVE: The primary objective is to evaluate the iCAST covered stent to a performance metric derived from studies of FDA-approved iliac stent devices for treating iliac artery stenoses in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
NUMBER OF SUBJECTS: 165 subjects, including up to 25 subjects with totally occluded lesions.
PRIMARY ENDPOINTS: The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization or restenosis (by ultrasound determination) within 9 months post-procedure.
SECONDARY ENDPOINTS: Secondary endpoints include:
- Major adverse vascular events (MAVE) defined as a composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, defined as causing end-organ damage (e.g. lower extremity ulceration, tissue necrosis, or gangrene), arterial rupture, acute limb ischemia, target limb amputation or procedure related bleeding event requiring transfusion.
- A major adverse event (MAE) is defined as a composite rate of MAVE or any death, or stroke, up to 30 days post-procedure.
- Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system.
- Acute procedural success, defined as device success and achievement of < 30% residual stenosis immediately after stent deployment, mean transtenotic pressure gradient of < 5 mmHg and without occurrence of in-hospital MAVE.
- Clinical success, assessed both early (30 days) and late (6, 9 and 12 months).
- Patency assessed at each follow-up time point, categorized as primary, primary-assisted or secondary patency.
- Composite rate of 30 day death, 9 month target site revascularization and 9 month restenosis in subjects without iliac total occlusions.
PATIENT POPULATION: Eligible patients have symptomatic claudication or rest pain and angiographic confirmation of either de novo or restenotic lesions in the common and/or external iliac artery.
- Conditions
- Peripheral Vascular Disease
- Being tested
- iCAST covered stent
- Keywords
- Symptomatic claudication or rest pain and angiographic confirmation of either de novo or restenotic lesions in the common and/or external iliac artery.
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCAST covered stentDevice
Iliac stent implantation
| Study group | Role | What they receive |
|---|---|---|
| iCAST covered stent | Other | This is a one arm trial. All subjects received the iCAST covered stent. Receives: Device: iCAST covered stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis
The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization within 9 months or restenosis (by ultrasound determination) at 9 months.
Measured: Within 9 Months post-procedure
Secondary outcomes (31)
Acute Procedural Success
Device success and achievement of < 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE.
Measured: Post-procedure
Device Success
Successful delivery and deployment of the study stent and intact retrieval of the delivery system.
Measured: Post-procedure
Major Adverse Event (MAE)
Composite rate of MAVE or any death, or stroke.
Measured: 30 Days
Major Adverse Vascular Event (MAVE)
Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.
Measured: 30 Days
Major Adverse Vascular Event (MAVE)
Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.
Measured: 180 Days
Major Adverse Vascular Event (MAVE)
Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.
Measured: 270 Days
Major Adverse Vascular Event (MAVE)
Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.
Measured: 360 Days
Early Clinical Success
Improvement of the Rutherford-Becker clinical criteria by ≥ 1 category. (Classification system for evaluating clinical improvement as defined by Rutherford R, Becker G. Standards for evaluating and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. Journal of Vascular Interventional Radiology 1991;2:169-174.)
Measured: 1 Month
Late Clinical Success
Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.
Measured: 6 Months
Late Clinical Success
Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.
Measured: 9 Months
Late Clinical Success
Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.
Measured: 12 Months
Late Clinical Success
Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.
Measured: 24 Months
Late Clinical Success
Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.
Measured: 36 Months
Primary Patency
Continuous flow without revascularization, bypass or target limb amputation.
Measured: 1 Month
Primary Patency
Continuous flow without revascularization, bypass or target limb amputation.
Measured: 6 Months
Primary Patency
Continuous flow without revascularization, bypass or target limb amputation.
Measured: 9 Months
Primary Patency
Continuous flow without revascularization, bypass or target limb amputation.
Measured: 12 Months
Primary Patency
Continuous flow without revascularization, bypass or target limb amputation.
Measured: 24 Months
Primary Patency
Continuous flow without revascularization, bypass or target limb amputation.
Measured: 36 Months
Primary-Assisted Patency
Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Measured: 1 Month
Primary-Assisted Patency
Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Measured: 6 Months
Primary-Assisted Patency
Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Measured: 9 Months
Primary-Assisted Patency
Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Measured: 12 Months
Primary-Assisted Patency
Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Measured: 24 Months
Primary-Assisted Patency
Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Measured: 36 Months
Secondary Patency
Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Measured: 1 Month
Secondary Patency
Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Measured: 6 Months
Secondary Patency
Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Measured: 9 Months
Secondary Patency
Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Measured: 12 Months
Secondary Patency
Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Measured: 24 Months
Secondary Patency
Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionAug 2011
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrium Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John R Laird, MD, Principal investigator, Adventist Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593385
- Sponsor's protocol ID
- Atrium 701
- Acronym
- iCARUS
- Status last verified
- Apr 2018
- First submitted
- 2 Jan 2008
- Last updated
- 17 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Laird JR, Loja M, Zeller T, Niazi KAK, Foster MT, Ansel G, Stone DH, Dave RM, Popma JJ, Jaff MR, Massaro JM. iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study. J Vasc Interv Radiol. 2019 Jun;30(6):822-829.e4. doi: 10.1016/j.jvir.2018.12.707. Epub 2019 Apr 25.
PubMed 31031089
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrium iCAST Iliac Stent Pivotal Study
- ClinicalTrials.gov ID
- NCT00593385
- Acronym / sponsor ID
- iCARUS / Atrium 701
- Conditions
- Peripheral Vascular Disease
- Keywords
- Symptomatic claudication or rest pain and angiographic confirmation of either de novo or restenotic lesions in the common and/or external iliac artery.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Atrium Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 17 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, non-randomized, single-arm registry to evaluate the safety and effectiveness of the iCAST Covered Stent System in the treatment of patients with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.
Detailed description
STUDY DESIGN: Prospective, multicenter, non-randomized, single-arm registry
OBJECTIVE: The primary objective is to evaluate the iCAST covered stent to a performance metric derived from studies of FDA-approved iliac stent devices for treating iliac artery stenoses in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
NUMBER OF SUBJECTS: 165 subjects, including up to 25 subjects with totally occluded lesions.
PRIMARY ENDPOINTS: The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization or restenosis (by ultrasound determination) within 9 months post-procedure.
SECONDARY ENDPOINTS: Secondary endpoints include:
- Major adverse vascular events (MAVE) defined as a composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, defined as causing end-organ damage (e.g. lower extremity ulceration, tissue necrosis, or gangrene), arterial rupture, acute limb ischemia, target limb amputation or procedure related bleeding event requiring transfusion.
- A major adverse event (MAE) is defined as a composite rate of MAVE or any death, or stroke, up to 30 days post-procedure.
- Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system.
- Acute procedural success, defined as device success and achievement of < 30% residual stenosis immediately after stent deployment, mean transtenotic pressure gradient of < 5 mmHg and without occurrence of in-hospital MAVE.
- Clinical success, assessed both early (30 days) and late (6, 9 and 12 months).
- Patency assessed at each follow-up time point, categorized as primary, primary-assisted or secondary patency.
- Composite rate of 30 day death, 9 month target site revascularization and 9 month restenosis in subjects without iliac total occlusions.
PATIENT POPULATION: Eligible patients have symptomatic claudication or rest pain and angiographic confirmation of either de novo or restenotic lesions in the common and/or external iliac artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iCAST covered stent | Other | Device: iCAST covered stentThis is a one arm trial. All subjects received the iCAST covered stent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is 18 years of age or older.
- Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4).
- Presence of de novo and/or restenotic lesions in the common and/or external iliac artery.
- Subject has single, bilateral or multiple target lesions that is (are) ≥ 50% stenosed by visual estimate.
- The target lesion(s) can be successfully crossed with a guide wire and dilated.
Key exclusion criteria (20 listed)
- Presence of other non-target ipsilateral arterial lesions requiring treatment within 30 days post-procedure (Note that treatment of ipsilateral SFA lesions may be allowed under certain circumstances). Treatment of lesions in any other vascular bed must be completed at least 30 days prior to enrollment.
- The target lesion(s) has adjacent, acute thrombus.
- The target lesion(s) is highly calcified or was previously treated with a stent.
- Target lesion involves the internal iliac artery resulting in crossing of the side-branch with the iCAST device (e.g. "jailing" of the side-branch).
- Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion.
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 |
|---|---|---|
| iCAST covered stentIliac stent implantation | Device | iCAST covered stent |
Primary outcome
Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis
Time frame: Within 9 Months post-procedure
The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization within 9 months or restenosis (by ultrasound determination) at 9 months.
31 secondary outcomes
Acute Procedural Success
Time frame: Post-procedure
Device Success
Time frame: Post-procedure
Major Adverse Event (MAE)
Time frame: 30 Days
Major Adverse Vascular Event (MAVE)
Time frame: 30 Days
Major Adverse Vascular Event (MAVE)
Time frame: 180 Days
Major Adverse Vascular Event (MAVE)
Time frame: 270 Days
Major Adverse Vascular Event (MAVE)
Time frame: 360 Days
Early Clinical Success
Time frame: 1 Month
Late Clinical Success
Time frame: 6 Months
Late Clinical Success
Time frame: 9 Months
Late Clinical Success
Time frame: 12 Months
Late Clinical Success
Time frame: 24 Months
Late Clinical Success
Time frame: 36 Months
Primary Patency
Time frame: 1 Month
Primary Patency
Time frame: 6 Months
Primary Patency
Time frame: 9 Months
Primary Patency
Time frame: 12 Months
Primary Patency
Time frame: 24 Months
Primary Patency
Time frame: 36 Months
Primary-Assisted Patency
Time frame: 1 Month
Primary-Assisted Patency
Time frame: 6 Months
Primary-Assisted Patency
Time frame: 9 Months
Primary-Assisted Patency
Time frame: 12 Months
Primary-Assisted Patency
Time frame: 24 Months
Primary-Assisted Patency
Time frame: 36 Months
Secondary Patency
Time frame: 1 Month
Secondary Patency
Time frame: 6 Months
Secondary Patency
Time frame: 9 Months
Secondary Patency
Time frame: 12 Months
Secondary Patency
Time frame: 24 Months
Secondary Patency
Time frame: 36 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31031089Laird JR, Loja M, Zeller T, Niazi KAK, Foster MT, Ansel G, Stone DH, Dave RM, Popma JJ, Jaff MR, Massaro JM. iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study. J Vasc Interv Radiol. 2019 Jun;30(6):822-829.e4. doi: 10.1016/j.jvir.2018.12.707. Epub 2019 Apr 25.
- Individual participant dataSharing planned: Undecided
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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.
John R Laird, MD principal investigator
Adventist Health
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCAST covered stent in people with Peripheral Vascular Disease, run by Atrium Medical Corporation at 25 sites in 2 countries.
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 10 inclusion and 20 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 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Germany. 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?
Yes. Results are posted in the registry (first posted 17 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis (time frame: Within 9 Months post-procedure). 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 NCT00593385, 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 17 May 2018.