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Myocardial IschemiaPhase 3SPIRIT PRIMENCT00916370

SPIRIT PRIME Clinical Trial

A Phase 3 study testing Core size Xience Prime and Xience Prime Long Lesion (LL) in people with Myocardial Ischemia and Coronary Artery Stenosis, run by Abbott Medical Devices at 62 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary artery lesions, each in a different… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Core size Xience Prime and Xience Prime Long Lesion (LL)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
525 participants
Where
62 sitesin 2 countries
Study dates
Jun 2009to Feb 2014
Phase
Phase 3
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 must be at least 18 years of age.
  • Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
  • Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
  • Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  • Subject must agree to undergo all protocol-required follow-up procedures.
  • Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.
Show all 17Show fewer
  • Angiographic Inclusion Criteria
  • One or two de novo target lesions each in a different epicardial vessel.
  • If there are two target lesions, both lesions must satisfy the angiographic eligibility criteria for that registry.
  • o Multiple focal de novo lesions in a target vessel that can be covered by a single stent are allowed.
  • The target lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
  • Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of:
  • ≥ 2.25 mm and ≤ 4.25 mm for treatment by the core size XIENCE PRIME EECS
  • ≥ 2.5 mm and ≤ 4.25 mm for treatment by the XIENCE PRIME LL EECS
  • Target lesion(s) must be located in a native coronary artery with length by visual estimation of:
  • ≤ 22 mm for treatment by the core size XIENCE PRIME EECS
  • > 22 mm and ≤ 32 mm for treatment by the XIENCE PRIME LL EECS

Who cannot join

  • Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.
  • The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
  • Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
  • Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
  • Subject has received coronary brachytherapy in any epicardial vessel (target or non target).
  • Subject has received any organ transplant or is on a waiting list for any organ transplant.
Show all 38Show fewer
  • Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
  • Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.
  • Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
  • Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
  • Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.
  • Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  • Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.
  • Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
  • Subject has known renal insufficiency (examples being but not limited to estimated glomerular filtration rate (eGFR) < 60 ml/kg/m2, serum creatinine level ≥ 2.5 mg/dL, or on dialysis).
  • Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
  • Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
  • Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
  • Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
  • Subject is currently participating in another clinical study that has not yet completed its primary endpoint.
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
  • Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.
  • Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft.
  • Target lesion involving a bifurcation with a side branch ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guide wire, or side branch requiring dilatation.
  • Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.
  • Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.
  • Restenotic target lesion.
  • Aorto-ostial target lesion (within 3 mm of the aorta junction).
  • Target lesion is in a left main location.
  • Target lesion located within 2 mm of the origin of the LAD or LCX.
  • Extreme angulation (≥ 90 °) or excessive tortuosity (≥ two 45° angles) proximal to or within the lesion.
  • Heavy calcification proximal to or within the target lesion.
  • Target vessel contains thrombus as indicated in the angiographic images.
  • Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon).
  • Target vessel is previously treated with any type of PCI (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure.
  • Non-target vessel is previously treated with any type of PCI < 90 days prior to the index procedure.
  • Additional clinically significant lesion(s) (e.g. %DS ≥ 50%) in a target vessel or side branch for which PCI may be required < 90 days after the index procedure.

Trial locations and contacts

62 sites in 2 countries.

62 sites in 2 countries

United States56 sites

  • Northwest Texas Healthcare System

    Amarillo, Texas, 79106

  • AnMed Health

    Anderson, South Carolina, 29621

  • Heart Hospital of Austin

    Austin, Texas, 78756

  • Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Bay Regional Medical Center

    Bay City, Michigan, 48706

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • St. Joseph Hospital

    Bellingham, Washington, 98225

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Cooper Health System

    Camden, New Jersey, 08103

  • Presbyterian Hospital - Charlotte

    Charlotte, North Carolina, 28233

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Morton Plant Hospital

    Clearwater, Florida, 33765

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • EMH Regional Medical Center

    Elyria, Ohio, 44035

  • Thomas Hospital

    Fairhope, Alabama, 36532

  • Pinnacle Health @ Harrisburg Hospital

    Harrisburg, Pennsylvania, 17043

  • St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46260

  • St. Vincents Medical Center

    Jacksonville, Florida, 32204

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • St. Patrick Hospital

    Missoula, Montana, 59802

  • Gotham Cardiology

    New York, New York, 10011

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Orlando Regional Medical Center

    Orlando, Florida, 32806

  • The Methodist Hospital

    Pearland, Texas, 77581

  • Sacred Heart Hospital of Pensicola

    Pensacola, Florida, 32504-8721

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Mercy General Hospital

    Sacramento, California, 95819

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85260

  • Willis Knighton Health System, Pierremont

    Shreveport, Louisiana, 71105

  • Sanford USD Medical Center

    Sioux Falls, South Dakota, 57104

  • Heart Clinics Northwest/ Sacred Heart Medical Center

    Spokane, Washington, 99204

  • St. John's Hospital

    Springfield, Illinois, 62701

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Hillcrest Medical Center

    Tulsa, Oklahoma, 74104

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Iowa Heart Center P.C.

    West Des Moines, Iowa, 50314

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Australia6 sites

  • Wesley Hospital

    Auchenflower, Queensland

  • The Prince Charles Hospital

    Chermside, Queensland, 4061

  • Monash Heart

    Clayton, Victoria, 3168

  • St. Vincent's Hospital

    Melbourne, Victoria, 3065

  • Royal Perth Hospital

    Perth, Western Australia

  • Epworth Hospital

    Richmond, Victoria, 3121

Other trials in Australia

About this study

Official title: SPIRIT PRIME Clinical Trial.

To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary artery lesions, each in a different epicardial vessel.

Being tested
Core size Xience Prime, Xience Prime Long Lesion (LL)
Keywords
drug eluting stents, stents, Angioplasty, myocardial ischemia, coronary artery stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Long lesion
Medical subject headings
Myocardial Ischemia, Coronary Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Core size Xience PrimeDevice

    Core size includes a range of stent sizes.

  • Xience Prime Long Lesion (LL)Device

    Long lesion stent sizes include a range of sizes.

Study groups in NCT00916370
Study groupRoleWhat they receive
Core size registry (CSR)ExperimentalCore size indicates the range of diameters of the stents used.
Receives: Device: Core size Xience Prime
Long lesion registry (LLR)ExperimentalUse of long lesion stents.
Receives: Device: Xience Prime Long Lesion (LL)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Lesion Failure (TLF)

    The composite rate of:

    Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

    Measured: 1 year

  2. Target Lesion Failure (TLF)

    The composite rate of:

    Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

    Measured: 2 years

  3. Target Lesion Failure (TLF)

    The composite rate of:

    Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

    Measured: 3 years

Secondary outcomes (82)

  1. Procedure Time

    Procedure time is defined as time between insertion and withdrawal of guide catheter.

    Measured: From insertion to withdrawal of guide catheter

  2. Device Success (Lesion Basis)

    Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).

    Measured: From the start of index procedure to end of index procedure

  3. Procedural Success (Subject Basis)

    Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.

    Measured: From the start of index procedure to end of index procedure

  4. All Death (Cardiac, Vascular, Non-cardiovascular)

    Measured: In-hospital is less than or equal to 7 days post index procedure

  5. All Death (Cardiac, Vascular, Non-cardiovascular)

    Measured: 30 days

  6. All Death (Cardiac, Vascular, Non-cardiovascular)

    Measured: 180 days

  7. All Death (Cardiac, Vascular, Non-cardiovascular)

    Measured: 1 year

  8. All Death (Cardiac, Vascular, Non-cardiovascular)

    Measured: 2 years

  9. All Death (Cardiac, Vascular, Non-cardiovascular)

    Measured: 3 years

  10. Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)

    Per Protocol

    Measured: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.

  11. Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)

    Per Protocol

    Measured: 30 days

  12. Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)

    Per Protocol

    Measured: 180 days

  13. Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)

    Per Protocol

    Measured: 1 year

  14. Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)

    Per Protocol

    Measured: 2 years

  15. Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)

    Per Protocol

    Measured: 3 years

  16. Non-target Vessel MI (Q-wave, Non Q-wave)

    Per Protocol

    Measured: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

  17. Non-target Vessel MI (Q-wave, Non Q-wave)

    Per Protocol

    Measured: 30 days

  18. Non-target Vessel MI (Q-wave, Non Q-wave)

    Per Protocol

    Measured: 180 days

  19. Non-target Vessel MI (Q-wave, Non Q-wave)

    Per Protocol

    Measured: 1 year

  20. Non-target Vessel MI (Q-wave, Non Q-wave)

    Per Protocol

    Measured: 2 years

  21. Non-target Vessel MI (Q-wave, Non Q-wave)

    Per Protocol

    Measured: 3 years

  22. Clinically Indicated-Target Lesion Revascularization

    Measured: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

  23. Clinically Indicated-Target Lesion Revascularization

    Measured: 30 days

  24. Clinically Indicated-Target Lesion Revascularization

    Measured: 180 days

  25. Clinically Indicated-Target Lesion Revascularization

    Measured: 1 year

  26. Clinically Indicated-Target Lesion Revascularization

    Measured: 2 years

  27. Clinically Indicated-Target Lesion Revascularization

    Measured: 3 years

  28. Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)

    Measured: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

  29. Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)

    Measured: 30 days

  30. Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)

    Measured: 180 days

  31. Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)

    Measured: 1 year

  32. Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)

    Measured: 2 years

  33. Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)

    Measured: 3 years

  34. All TLR (CI and Non-CI)

    Measured: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

  35. All TLR (CI and Non-CI)

    Measured: 30 days

  36. All TLR (CI and Non-CI)

    Measured: 180 days

  37. All TLR (CI and Non-CI)

    Measured: 1 year

  38. All TLR (CI and Non-CI)

    Measured: 2 years

  39. All TLR (CI and Non-CI)

    Measured: 3 years

  40. All TVR (CI and Non-CI)

    Measured: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

  41. All TVR (CI and Non-CI)

    Measured: 30 days

  42. All TVR (CI and Non-CI)

    Measured: 180 days

  43. All TVR (CI and Non-CI)

    Measured: 1 year

  44. All TVR (CI and Non-CI)

    Measured: 2 years

  45. All TVR (CI and Non-CI)

    Measured: 3 years

  46. All Coronary Revascularization (TVR and Non-TVR)

    Measured: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

  47. All Coronary Revascularization (TVR and Non-TVR)

    Measured: 30 days

  48. All Coronary Revascularization (TVR and Non-TVR)

    Measured: 180 days

  49. All Coronary Revascularization (TVR and Non-TVR)

    Measured: 1 year

  50. All Coronary Revascularization (TVR and Non-TVR)

    Measured: 2 years

  51. All Coronary Revascularization (TVR and Non-TVR)

    Measured: 3 years

  52. Cardiac Death/All MI

    Measured: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

  53. Cardiac Death/ All MI

    Per Protocol

    Measured: 30 days

  54. Cardiac Death/All MI

    Per Protocol

    Measured: 180 days

  55. Cardiac Death/All MI

    Per Protocol

    Measured: 1 year

  56. Cardiac Death/All MI

    Per Protocol

    Measured: 2 years

  57. Cardiac Death/All MI

    Per Protocol

    Measured: 3 years

  58. Cardiac Death/ All MI/CI-TLR

    Measured: in-hospital

  59. Cardiac Death/ All MI/CI-TLR

    Per Protocol

    Measured: 30 days

  60. Cardiac Death/ All MI/CI-TLR

    Per Protocol

    Measured: 180 days

  61. Cardiac Death/ All MI/CI-TLR

    Per Protocol

    Measured: 1 year

  62. Cardiac Death/ All MI/CI-TLR

    Per Protocol

    Measured: 2 years

  63. Cardiac Death/ All MI/CI-TLR

    Per Protocol

    Measured: 3 years

  64. All Death/All MI/All Coronary Revascularization

    Per Protocol

    Measured: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

  65. All Death/All MI/All Coronary Revascularization

    Per Protocol

    Measured: 30 days

  66. All Death/All MI/All Coronary Revascularization

    Per Protocol

    Measured: 180 days

  67. All Death/All MI/All Coronary Revascularization

    Per Protocol

    Measured: 1 year

  68. All Death/All MI/All Coronary Revascularization

    Per Protocol

    Measured: 2 years

  69. All Death/All MI/All Coronary Revascularization

    Per Protocol

    Measured: 3 years

  70. Stent Thrombosis

    Per protocol and per Academic Research Consortium (ARC, definite/probable)

    Measured: Acute (≤1 day)

  71. Stent Thrombosis

    Per protocol and per ARC

    Measured: Subacute (>1 - 30 days)

  72. Stent Thrombosis

    Per protocol and per ARC

    Measured: Acute/Subacute (0 - 30 days)

  73. Stent Thrombosis

    Per protocol and per ARC

    Measured: Late (31 - 393 days)

  74. Stent Thrombosis

    Per protocol

    Measured: Late (31 - 758 days)

  75. Stent Thrombosis

    Per ARC, definite and probable

    Measured: Very Late (394 - 758 days)

  76. Stent Thrombosis

    Per protocol

    Measured: Late (31 - 1123 days)

  77. Stent Thrombosis

    Per ARC, definite and probable

    Measured: Very Late (394 - 1123 days)

  78. Stent Thrombosis

    Per protocol and per ARC

    Measured: Overall (0-393 days)

  79. Stent Thrombosis

    Per protocol

    Measured: Overall (0-758 days)

  80. Stent Thrombosis

    Per ARC, definite and probable

    Measured: Overall (0-758 days)

  81. Stent Thrombosis

    Per protocol

    Measured: Overall (0 - 1123 days)

  82. Stent Thrombosis

    Per ARC, definite and probable

    Measured: Overall (0 - 1123 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionMar 2011
  4. Study completionFeb 2014

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
525 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00916370
Sponsor's protocol ID
06-373
Acronym
SPIRIT PRIME
Status last verified
May 2015
First submitted
5 Jun 2009
Last updated
8 Jun 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Core size Xience Prime and Xience Prime Long Lesion (LL) in people with Myocardial Ischemia and Coronary Artery Stenosis, run by Abbott Medical Devices at 62 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 17 inclusion and 38 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Australia. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2012). 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?

Target Lesion Failure (TLF) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT00916370.

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 8 Jun 2015.

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