Coronary Artery DiseasePhase 4ABCDNCT01192724
Additional Benefit of Cilostazol to Dual Antiplatelet Therapy After Biolimus-eluting Stent Implantation
A Phase 4 study testing Cilostazol, Aspirin and Clopidogrel in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Because there is limited data about long-term efficacy and safety about short-term use of cilostazol adding to dual antiplatelet therapy in patients with long or multivessel coronary artery disease after 2nd generation DES implantation, especially in biodegradable polymer stent, the investigators will evaluate whether… 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?
- Cilostazol, Aspirin and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Dec 2012
- Phase
- Phase 4
- 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
- Age > 18 years.
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the BioMatrix® and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have significant coronary artery stenosis (>70% by visual estimate).
- Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, silent ischemia, positive functional study or a reversible changes in the ECG consistent with ischemia).
- Target lesion(s) located in a native coronary artery with visually estimated diameter of ≥ 2.0 and ≤ 4.24 mm
- Target lesion(s) amenable for PCI
Show all 11Show fewer
- Lesion(s) must have at least 1 of these 2 angiographic features to be eligible
- Lesion(s) need(s) stent length ≥ 28mm (multiple stents whether are overlapped or not are allowed. No limitation of stent length)
- Multivessel coronary artery disease that need ≥2 stents regardless of stent length
- Significant (>70%) lesions in at least two major epicardial vessels (≥ 2.0mm in diameter)
- Lesion(s) of chronic total occlusion or bifurcation which need ≥ 2 stents can be eligible
Who cannot join
- The subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, biolimus A9, stainless steel, cobalt chromium, contrast media*. (*Subjects with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. However, those with true anaphylaxis to prior contrast media should not be enrolled.)
- Systemic (intravenous) biolimus A9 use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
Show all 16Show fewer
- An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Subjects who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Subjects who have received DES implantation in the any coronary artery prior to enrollment
- Subjects with heart failure, NYHA class III or IV or those with cardiogenic shock. (The degree of left ventricular ejection fraction is not considered as an index of exclusion)
- Creatinine level > 3.0mg/dL or dependence on dialysis.
- Severe hepatic dysfunction AST or ALT > 3 times upper normal reference values) except MI-induced elevation
- Subjects who need antagonist of vitamin K due during study
- Isolated left main disease (lesion(s) at proximal LAD or LCX lesion that need to cross the left main can be enrolled)
- Target lesion(s) with ISR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial of Evaluating Additional Benefit of Cilostazol to Dual Antiplatelet Therapy in Patients With Long or Multi-vessel Coronary Artery Disease Underwent Biolimus-Eluting Stent Implantation
Because there is limited data about long-term efficacy and safety about short-term use of cilostazol adding to dual antiplatelet therapy in patients with long or multivessel coronary artery disease after 2nd generation DES implantation, especially in biodegradable polymer stent, the investigators will evaluate whether a 3-month use of cilostazol in addition to dual antiplatelet therapy effectively reduces clinical adverse outcome at 1 year in subject with long or multivessel coronary artery disease after biolimus-eluting stent implantation.
Read the detailed description
Previous randomized trials have shown the efficacy of drug-eluting stent (DES) such as sirolimus-eluting stent (CYPHERTM, Cordis, Warren, NJ, USA), paclitaxel-eluting stent (TAXUSTM, BostonScientific, Natick, MA, USA), and zotarolimus-eluting stent (Endeavor,Medtronic,Minneapolis, MN, USA) over bare metal stents (BMS) in reducing neointimal hyperplasia, late luminal loss, and angiographic restenosis leading to decreased target lesion revascularization.1-4 In addition, Among patients with off-label indications, the use of DESs reduced a rate of repeat revascularization without increasing the risk of death or myocardial infarction, as compared with bare-metal stents.5 But, compared with on-label use, off-label use of DESs is associated with a higher rate of adverse outcomes such as death, myocardial infarction and target vessel revascularization. Furthermore, stent thrombosis (ST) occurred predominantly in patients who underwent off-label DES implantation.6 It is known that the risk of adverse cardiac events and ST after DES implantation is related to stent length.7 Cilostazol is a potent phosphodiesterase III inhibitor preventing the hydrolysis of cAMP in platelets and vascular smooth muscle cell. The novel mechanism of action of cilostazol reduces the number of circulating, partially activated, or preconditioned platelets, by reducing the surface expression of adhesive molecules in endothelial cells interacting with circulating platelets. The agent also directly inhibits platelet aggregation induced by a variety of stimuli, including arachidonic acid, ADP, collagen, thrombin, and high shear stress.8 In current guidelines, a 12-month duration of dual antiplatelet therapy with aspirin and clopidogrel is recommended after DES implantation.9 But, recent meta-analyses showed a potential benefit of cilostazol in addition to dual antiplatelet therapy in reducing angiographic restenosis and improved clinical outcomes after BMS or DES implantation.10, 11 Actually, additional cilostazol to dual antiplatelet therapy showed reduced restenosis and late loss in patients with long coronary lesion and diabetes with multivessel coronary artery disease and it also showed beneficial effect on stent thrombosis after DES implantation.12-14 Although most studies showed no difference in bleeding according to additional cilostazol to dual antiplatelet therapy, the rate of early cessation of cilostazol due to adverse effect including headache, palpitation, skin rash and hepatic dysfunction was about 15%.12-14 Because of relatively higher side effect rate and no definitive duration of addition cilostazol use, we expect that cilostazol with short duration can be easily accepted to patient. Although almost studies about cilostazol after stent implantation used a 6- month duration of cilostazol, one study showed that use of cilostazol for 3 months after percutaneous transluminal coronary balloon angioplasty reduced restenosis and revascularization, as compared with use of aspirin.15 So, we expect a 3-month use of additional cilostazol to dual antiplatelet therapy can reduce the adverse outcome and ST after stent implantation without increasing early cessation of cilostazol.
The BioMatrixTM stent system (Biosensors Interventional Technologies Pte., Ltd, Singapore) consist of a stainless steel, quadrature-link design, balloon expandable S-StentTM, and a polylactic acid (PLA) polymer and BiolimusA9® coating mounted on a low-profile delivery catheter.16, 17 It is expected that abluminal biodegradable coating of BioMatrixTM stent can lead to more targeted drug release, reduced systemic exposure and early BMS-like endothelial coverage.18 The first-in-man, randomized controlled SEALTH I trial demonstrate higher efficacy of BioMatrixTM stent by showing lower late lumen loss and in-stent restenosis as compared with BMS, S-stent at 6-month follow-up.19 In LEADERS trial, BioMatrixTM stent showed similar efficacy and safety as compared with sirolimus-eluting stent in patients with chronic stable coronary artery disease and acute coronary syndromes.20 But significantly lower uncovered and malapposed struts was detected by optical coherence tomography study.21 This means more complete coverage of struts and we can expect lower late ST after BioMatrixTM stent implantation.
- Conditions
- Coronary Artery Disease
- Being tested
- Cilostazol, Aspirin, Clopidogrel
- Keywords
- Antiplatelet, Coronary artery diseae, Percutaneous coronary intervention
- 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.
CilostazolDrug
Also called pletaal
100 mg BID, for 3 months
AspirinDrug
Also called Aspirin protect, Astrix, Baby rhonal
Aspirin 100 mg QD, for 1 year
ClopidogrelDrug
Also called Plavix, Plavitor, Platless
Clopidogrel 75 mg QD, for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Triple antiplatelet therapy (TAPT) group | Active comparator | 3-month use of cilostazol in addition to dual antiplatelet agent Receives: Drug: Cilostazol; Drug: Aspirin; Drug: Clopidogrel |
| Dual antiplatelet therapy (DAPT) group | Active comparator | Aspirin and clopidogrel (dual antiplatelet therapy, DAPT) for 1 year Receives: Drug: Aspirin; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-oriented composite
Device-oriented composite was defined as a composite of cardiac death, MI (not clearly attributable to a non-target vessel), and clinically indicated target lesion revascularization (TLR).
Measured: One year
Secondary outcomes (4)
Patient-oriented composite
Patient-oriented composite was defined as a composite of all-cause mortality, any MI (includes non-target vessel territory), and any repeat revascularization (includes all target and non-target vessel).
Measured: One year
Each component of device- and patient-oriented composite
All-cause mortality, cardiac death, any myocardial infarction (MI), MI (not clearly attributable to a non-target vessel), clinically indicated target lesion revascularization (TLR), and any repeat revascularization (includes all target and non-target vessel)
Measured: One year
Academic Research Consortium (ARC) defined stent thrombosis
definite, probable, and possible stent thrombosis / acute, subacute, and late stent thrombosis
Measured: One year
Safety assessments
Safety assessments will be performed for bleeding complication according to Thrombolysis In Myocardial Infarction (TIMI) criteria, medication compliance, side effect of drug, and heart rate.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionDec 2012
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.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoon Junghan, Yonsei University
- Investigators
- Junghan Yoon, M.D., Ph.D., Principal investigator, Wonju College of Medicine, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192724
- Sponsor's protocol ID
- ABCD
- Acronym
- ABCD
- Status last verified
- Nov 2016
- First submitted
- 31 Aug 2010
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Youn YJ, Lee JW, Ahn SG, Lee SH, Choi H, Yu CW, Hong YJ, Kwon HM, Hong MK, Jang Y, Yoon J. Multicenter randomized trial of 3-month cilostazol use in addition to dual antiplatelet therapy after biolimus-eluting stent implantation for long or multivessel coronary artery disease. Am Heart J. 2014 Feb;167(2):241-248.e1. doi: 10.1016/j.ahj.2013.08.028. Epub 2013 Oct 22.
PubMed 24439986
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Evaluating Additional Benefit of Cilostazol to Dual Antiplatelet Therapy in Patients With Long or Multi-vessel Coronary Artery Disease Underwent Biolimus-Eluting Stent Implantation
- ClinicalTrials.gov ID
- NCT01192724
- Acronym / sponsor ID
- ABCD / ABCD
- Conditions
- Coronary Artery Disease
- Keywords
- Antiplatelet, Coronary artery diseae, Percutaneous coronary intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Sep 2010 (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.
Because there is limited data about long-term efficacy and safety about short-term use of cilostazol adding to dual antiplatelet therapy in patients with long or multivessel coronary artery disease after 2nd generation DES implantation, especially in biodegradable polymer stent, the investigators will evaluate whether a 3-month use of cilostazol in addition to dual antiplatelet therapy effectively reduces clinical adverse outcome at 1 year in subject with long or multivessel coronary artery disease after biolimus-eluting stent implantation.
Detailed description
Previous randomized trials have shown the efficacy of drug-eluting stent (DES) such as sirolimus-eluting stent (CYPHERTM, Cordis, Warren, NJ, USA), paclitaxel-eluting stent (TAXUSTM, BostonScientific, Natick, MA, USA), and zotarolimus-eluting stent (Endeavor,Medtronic,Minneapolis, MN, USA) over bare metal stents (BMS) in reducing neointimal hyperplasia, late luminal loss, and angiographic restenosis leading to decreased target lesion revascularization.1-4 In addition, Among patients with off-label indications, the use of DESs reduced a rate of repeat revascularization without increasing the risk of death or myocardial infarction, as compared with bare-metal stents.5 But, compared with on-label use, off-label use of DESs is associated with a higher rate of adverse outcomes such as death, myocardial infarction and target vessel revascularization. Furthermore, stent thrombosis (ST) occurred predominantly in patients who underwent off-label DES implantation.6 It is known that the risk of adverse cardiac events and ST after DES implantation is related to stent length.7 Cilostazol is a potent phosphodiesterase III inhibitor preventing the hydrolysis of cAMP in platelets and vascular smooth muscle cell. The novel mechanism of action of cilostazol reduces the number of circulating, partially activated, or preconditioned platelets, by reducing the surface expression of adhesive molecules in endothelial cells interacting with circulating platelets. The agent also directly inhibits platelet aggregation induced by a variety of stimuli, including arachidonic acid, ADP, collagen, thrombin, and high shear stress.8 In current guidelines, a 12-month duration of dual antiplatelet therapy with aspirin and clopidogrel is recommended after DES implantation.9 But, recent meta-analyses showed a potential benefit of cilostazol in addition to dual antiplatelet therapy in reducing angiographic restenosis and improved clinical outcomes after BMS or DES implantation.10, 11 Actually, additional cilostazol to dual antiplatelet therapy showed reduced restenosis and late loss in patients with long coronary lesion and diabetes with multivessel coronary artery disease and it also showed beneficial effect on stent thrombosis after DES implantation.12-14 Although most studies showed no difference in bleeding according to additional cilostazol to dual antiplatelet therapy, the rate of early cessation of cilostazol due to adverse effect including headache, palpitation, skin rash and hepatic dysfunction was about 15%.12-14 Because of relatively higher side effect rate and no definitive duration of addition cilostazol use, we expect that cilostazol with short duration can be easily accepted to patient. Although almost studies about cilostazol after stent implantation used a 6- month duration of cilostazol, one study showed that use of cilostazol for 3 months after percutaneous transluminal coronary balloon angioplasty reduced restenosis and revascularization, as compared with use of aspirin.15 So, we expect a 3-month use of additional cilostazol to dual antiplatelet therapy can reduce the adverse outcome and ST after stent implantation without increasing early cessation of cilostazol.
The BioMatrixTM stent system (Biosensors Interventional Technologies Pte., Ltd, Singapore) consist of a stainless steel, quadrature-link design, balloon expandable S-StentTM, and a polylactic acid (PLA) polymer and BiolimusA9® coating mounted on a low-profile delivery catheter.16, 17 It is expected that abluminal biodegradable coating of BioMatrixTM stent can lead to more targeted drug release, reduced systemic exposure and early BMS-like endothelial coverage.18 The first-in-man, randomized controlled SEALTH I trial demonstrate higher efficacy of BioMatrixTM stent by showing lower late lumen loss and in-stent restenosis as compared with BMS, S-stent at 6-month follow-up.19 In LEADERS trial, BioMatrixTM stent showed similar efficacy and safety as compared with sirolimus-eluting stent in patients with chronic stable coronary artery disease and acute coronary syndromes.20 But significantly lower uncovered and malapposed struts was detected by optical coherence tomography study.21 This means more complete coverage of struts and we can expect lower late ST after BioMatrixTM stent implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple antiplatelet therapy (TAPT) group | Active comparator | Drug: Cilostazol, Drug: Aspirin, Drug: Clopidogrel3-month use of cilostazol in addition to dual antiplatelet agent |
| Dual antiplatelet therapy (DAPT) group | Active comparator | Drug: Aspirin, Drug: ClopidogrelAspirin and clopidogrel (dual antiplatelet therapy, DAPT) for 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age > 18 years.
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the BioMatrix® and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have significant coronary artery stenosis (>70% by visual estimate).
- Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, silent ischemia, positive functional study or a reversible changes in the ECG consistent with ischemia).
- Target lesion(s) located in a native coronary artery with visually estimated diameter of ≥ 2.0 and ≤ 4.24 mm
Key exclusion criteria (16 listed)
- The subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, biolimus A9, stainless steel, cobalt chromium, contrast media*. (*Subjects with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. However, those with true anaphylaxis to prior contrast media should not be enrolled.)
- Systemic (intravenous) biolimus A9 use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
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 |
|---|---|---|
| CilostazolAlso: pletaal100 mg BID, for 3 months | Drug | Triple antiplatelet therapy (TAPT) group |
| AspirinAlso: Aspirin protect, Astrix, Baby rhonalAspirin 100 mg QD, for 1 year | Drug | Dual antiplatelet therapy (DAPT) group, Triple antiplatelet therapy (TAPT) group |
| ClopidogrelAlso: Plavix, Plavitor, PlatlessClopidogrel 75 mg QD, for 1 year | Drug | Dual antiplatelet therapy (DAPT) group, Triple antiplatelet therapy (TAPT) group |
Primary outcome
Device-oriented composite
Time frame: One year
Device-oriented composite was defined as a composite of cardiac death, MI (not clearly attributable to a non-target vessel), and clinically indicated target lesion revascularization (TLR).
4 secondary outcomes
Patient-oriented composite
Time frame: One year
Each component of device- and patient-oriented composite
Time frame: One year
Academic Research Consortium (ARC) defined stent thrombosis
Time frame: One year
Safety assessments
Time frame: One year
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 15 Nov 2016.
- Results publication: PubMed 24439986Youn YJ, Lee JW, Ahn SG, Lee SH, Choi H, Yu CW, Hong YJ, Kwon HM, Hong MK, Jang Y, Yoon J. Multicenter randomized trial of 3-month cilostazol use in addition to dual antiplatelet therapy after biolimus-eluting stent implantation for long or multivessel coronary artery disease. Am Heart J. 2014 Feb;167(2):241-248.e1. doi: 10.1016/j.ahj.2013.08.028. Epub 2013 Oct 22.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Junghan Yoon, M.D., Ph.D. principal investigator
Wonju College of Medicine, Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cilostazol, Aspirin and Clopidogrel in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
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 11 inclusion and 16 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 15 Nov 2016. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Device-oriented composite (time frame: One year). 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 NCT01192724, 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 15 Nov 2016.