True Coronary Bifurcation LesionsCOBRANCT01486095
COmplex BifuRcation Lesions: a Comparison Between the AXXESS Device and Culotte Stenting: an Optical Coherence Tomography (OCT) Study
A study testing AXXESS + Biomatrix Biolimus Eluting stent and Culotte technique with Xience V or Xience Prime stents in people with True Coronary Bifurcation Lesions, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
Treatment of bifurcation lesions with drug-eluting stents (DES) (especially when a double stent technique is used) is associated with a higher risk for stent thrombosis. Different factors may play a role in the higher risk for stent thrombosis in bifurcation lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- True Coronary Bifurcation Lesions
- What is being tested?
- AXXESS + Biomatrix Biolimus Eluting stent and Culotte technique with Xience V or Xience Prime stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBelgium
- Study dates
- 29 Nov 2011to Dec 2017
- 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
- Patient older than 18 years
- The subject has stable or unstable angina pectoris, or a positive functional study for ischemia.
- The subject is eligible for PCI, and is an acceptable candidate for coronary artery bypass surgery.
- The subject is male, or if female, has no childbearing potential or has had a negative urine or serum pregnancy test within 7 days of the index procedure and has no intention to become pregnant within a year of the procedure.
- The subject has signed the informed consent prior to the procedure, and agrees to comply with the follow up requirements.
- Patients with a de novo and true coronary bifurcation lesion (Medina classification (1,1,1), (1,0,1) or (0,1,1)).
Show all 11Show fewer
- Coronary artery with proximal parent vessel reference diameter of 2.75 - 3.75 mm and a branch vessel diameter of ≥ 2.25 mm.
- The lesion must be at least 50% diameter stenosis within either the MB or SB.
- Regarding lesion length: lesion should be able to be covered by 2 Xience Prime stents in a Culotte technique, or by a combination of maximally 1 AXXESS and 2 Biomatrix™ Drug Eluting Coronary Stents.
- The side branch ostium is located at least 12 mm from the left main coronary artery.
- The angle between the sidebranch and the parent vessel is less than 70°.
Who cannot join
- Left ventricular ejection fraction of < 30%
- Impaired renal function (serum creatinine > 2.0 mg/dl)
- Previous and/or planned brachytherapy of target vessel
- Lesion of the left main trunk > 50%, unprotected
- The target vessel contains intraluminal thrombus.
- The target lesion shows angiographic evidence of moderate to severe calcification or tortuosity.
Show all 13Show fewer
- Known allergies to antiplatelet, anticoagulation therapy, contrast media, everolimus or biolimus, stainless steel, cobalt, chromium, nickel or titanium
- Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
- Patients with a life expectancy of less than one year
- Patient currently enrolled in other investigational device or drug trial
- Patient not able or willing to adhere to follow-up visits
- Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
- Patients who previously participated in this study.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Comparison of Healing Responses After Treatment of Complex Bifurcation Lesions With a Dedicated Bifurcation Device (Axxess™ Drug Eluting Coronary Bifurcation Stent System + Biomatrix™ Drug Eluting Coronary Stent System Stents in the Distal Branches) Versus the Culotte Technique Using Xience Prime Everolimus-eluting Stents : an Optical Coherence Tomography (OCT) Analysis
Treatment of bifurcation lesions with drug-eluting stents (DES) (especially when a double stent technique is used) is associated with a higher risk for stent thrombosis. Different factors may play a role in the higher risk for stent thrombosis in bifurcation lesions. Possible mechanisms are delayed endothelialisation due to the action of the drug, coating polymers, or overlapping stent segments, incomplete stent apposition at specific sites in the bifurcation lesion and higher thrombogenicity due to turbulent flow at the bifurcation site. In human pathological data, the RUTSS (ratio of uncovered to total stent struts) appears to be the most powerful predictor of stent thrombosis.
This prospective study will assess the differences in stent strut coverage and stent strut apposition after complex bifurcation lesion treatment with the dedicated AXXESS Biolimus A9-eluting bifurcation stent at the bifurcation site and additional Biomatrix Biolimus A9-eluting stents in the distal main vessel and the side branch versus treatment with the culotte technique using the Xience Prime everolimus-eluting stents.
Read the detailed description
BACKGROUND: There is an ongoing controversy over the efficacy and safety of different bifurcation stenting techniques. Critical considerations are the rate of restenosis at the side branch ostium, and completeness of healing at sites of overlap of stent struts, which may affect the risk of stent thrombosis.
AIMS: To compare vessel healing at 9 months using OCT imaging for two different treatment techniques for treating bifurcation lesions. Quantitative assessment of OCT images will be used to assess re-endothelialisation and quality of strut apposition to the vessel wall.
METHODS: Patients with true bifurcation lesions with involvement of a significant side branch requiring a stent will be randomly assigned to one of two treatment strategies. Group A will comprise 20 patients which will be treated with the Axxess™ Drug Eluting Coronary Bifurcation Stent System (Biosensors Europe SA) where additional Biomatrix™ Drug Eluting Coronary Stent Systems (Biosensors Europe SA) are implanted into the distal main branch (MB) and the side branch (SB) as required. Group B will consist of 20 patients which will be treated with the culotte technique using Xience Prime everolimus-eluting stents (Abbott-Vascular, US). Kissing balloon dilatation using non-compliant balloons will complete the index procedure in all cases. At 9 months, control angiography for all patients (with QCA using dedicated software) and OCT (of both main vessel and side branch) will be performed.
ENROLMENT PLAN:
Start: Third quarter of 2011 Enrolment period: ± 12 months Clinical follow-up: 5 years Angiographic and OCT results expected third quarter of 2013
- Conditions
- True Coronary Bifurcation Lesions
- Being tested
- AXXESS + Biomatrix Biolimus Eluting stent, Culotte technique with Xience V or Xience Prime stents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXXESS + Biomatrix Biolimus Eluting stentDevice
NAP
Culotte technique with Xience V or Xience Prime stentsDevice
NAP
| Study group | Role | What they receive |
|---|---|---|
| AXXESS + Biomatrix | Experimental | After mandatory predilatation, a self-expanding, conically shaped nickel-titanium AXXESS biolimus A9-eluting stent is placed at the level of the carina. The device is available in 3.0 and 3.5 mm calibre and 11 and 14 mm length. Depending on the lesion anatomy, additional Biomatrix™ Drug Eluting Coronary Stent Systems are placed distally if necessary. The procedure is completed with kissing balloon postdilatation using non-compliant balloons sized to the reference vessel diameter of the distal branches. Before this kissing balloon inflation, consecutive high pressure inflations should be performed in both branches. Receives: Device: AXXESS + Biomatrix Biolimus Eluting stent |
| Culotte technique: Xience V/Prime | Active comparator | The culotte technique consists of stenting one of both branches of the bifurcation lesion first, and after balloon dilatation of the stent meshes, stenting the uncovered branch through the first stent and leaving the main vessel covered with two overlapped stents. The procedure is terminated by kissing balloon dilatation of both branches using non-compliant balloons sized to the reference vessel diameter of the distal branches. Before this kissing balloon inflation, consecutive high pressure inflations should be performed in both branches. Receives: Device: Culotte technique with Xience V or Xience Prime stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Percent uncovered to total stent struts at 9 months, assessed with OCT, in two different bifurcation stenting techniques
Measured: 9 months
Secondary outcomes (22)
Secondary endpoint : stent strut coverage per segment with OCT
- Percent uncovered to total stent struts at 9 months per analyzed bifurcation segment (proximal MB, carina, distal MB, SB)
Measured: 9 months
Secondary endpoint: stent strut apposition with OCT
- Percent malapposed to total stent struts at 9 months post procedure, both overall and per bifurcation segment
Measured: 9 months
Secondary endpoint: clusters of malapposition with OCT
- Number of clusters of malapposition, overall and per bifurcation segment. Per cluster, the number of malapposed struts, the area (mm²), the volume (mm³) and the arc (degrees) of malapposition will be assessed.
Measured: 9 months
Secondary endpoint: Tissue strut thickness with OCT
- Tissue strut thickness at 9 months per bifurcation segment (µm)
Measured: 9 months
Secondary endpoint: neointimal hyperplasia volume
- Neointimal hyperplasia: absolute and percent volume of intimal hyperplasia at 9 months post procedure (mm³)
Measured: 9 months
Secondary endpoint: late luminal loss (angiography)
- Late Lumen Loss (in-stent) at 9 months
Measured: 9 months
Secondary endpoint: in-segment late luminal loss (angiography)
- In-segment Late Lumen Loss at 9 months (including stent + 5mm proximal and distal)
Measured: 9 months
Secondary endpoint: binary restenosis (angiography)
- Binary in-stent restenosis at 9 months
Measured: 9 months
Secondary endpoint: binary in-segment restenosis (angiography)
- Binary in-segment restenosis at 9 months (including stent + 5mm proximal and distal)
Measured: 9 months
Secondary endpoint: minimal lumen diameter (angiography)
- Minimal Lumen Diameter (MLD), in-stent and in-segment at 9 months
Measured: 9 months
Secondary endpoints: clinical: MACE
- Cumulative MACE rate (cardiac death, Q- or non-Q-wave MI, or clinically driven TLR) at 1, 8 and 12 months and annually for 5 years from the procedure date.
Measured: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoints: clinical: components of MACE: cardiac death
- Cumulative components of MACE: cardiac death at 1, 8 and 12 months and annually for 5 years from the procedure date.
Measured: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoints: clinical: components of MACE: Q- or non-Q-wave myocardial infarction
- Cumulative components of MACE :Q- or non-Q-wave MI at 1, 8 and 12 months and annually for 5 years from the procedure date.
Measured: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoints: clinical: components of MACE: clinically driven target lesion revascularization (TLR)
- Cumulative components of MACE : clinically driven TLR at 1, 8 and 12 months and annually for 5 years from the procedure date.
Measured: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoint: Stent thrombosis
- Stent thrombosis at at 24h, 1 month, 12 months and yearly thereafter (up to 5y)
Measured: 24h, 1 month, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: Target vessel revascularization
- Target vessel revascularisation (TVR) at at 1, 8, 12 months and yearly thereafter (up to 5y)
Measured: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: all-cause death
- All-cause death at 1, 8, 12 months and yearly thereafter (up to 5y)
Measured: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: non-target revascularization
non-Target vessel revascularization at 1, 8, 12 months and yearly thereafter (up to 5y)
Measured: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: any coronary revascularization
Any coronary revascularization 1, 8, 12 months and yearly thereafter (up to 5y)
Measured: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: device success
- Device success, defined as achievement of a final residual diameter stenosis of <30% measured by QCA.
Measured: Immediately after initial treatment of the study lesion
Secondary endpoint: lesion treatment success
- Lesion treatment success, defined as <30% residual stenosis in the MB and <50% in the SB measured by QCA by any treatment.
Measured: Immediately after initial treatment of the study lesion
Secondary endpoint: procedure success
- Procedure success, defined as lesion success without the occurrence of MACE during the hospital stay.
Measured: 24h after treatment of the target lesion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study start29 Nov 2011
- Primary completionDec 2013
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for True Coronary Bifurcation LesionsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Biosensors International
- Responsible party
- Principal investigator, Prof Dr Walter Desmet, University Hospital, Gasthuisberg
- Investigators
- Christophe L Dubois, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486095
- Sponsor's protocol ID
- UH Leuven S53441
- Acronym
- COBRA
- Status last verified
- May 2017
- First submitted
- 28 Nov 2011
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Healing Responses After Treatment of Complex Bifurcation Lesions With a Dedicated Bifurcation Device (Axxess™ Drug Eluting Coronary Bifurcation Stent System + Biomatrix™ Drug Eluting Coronary Stent System Stents in the Distal Branches) Versus the Culotte Technique Using Xience Prime Everolimus-eluting Stents : an Optical Coherence Tomography (OCT) Analysis
- ClinicalTrials.gov ID
- NCT01486095
- Acronym / sponsor ID
- COBRA / UH Leuven S53441
- Conditions
- True Coronary Bifurcation Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Biosensors International
- Study start
- 29 Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Dec 2011 (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.
Treatment of bifurcation lesions with drug-eluting stents (DES) (especially when a double stent technique is used) is associated with a higher risk for stent thrombosis. Different factors may play a role in the higher risk for stent thrombosis in bifurcation lesions. Possible mechanisms are delayed endothelialisation due to the action of the drug, coating polymers, or overlapping stent segments, incomplete stent apposition at specific sites in the bifurcation lesion and higher thrombogenicity due to turbulent flow at the bifurcation site. In human pathological data, the RUTSS (ratio of uncovered to total stent struts) appears to be the most powerful predictor of stent thrombosis.
This prospective study will assess the differences in stent strut coverage and stent strut apposition after complex bifurcation lesion treatment with the dedicated AXXESS Biolimus A9-eluting bifurcation stent at the bifurcation site and additional Biomatrix Biolimus A9-eluting stents in the distal main vessel and the side branch versus treatment with the culotte technique using the Xience Prime everolimus-eluting stents.
Detailed description
BACKGROUND: There is an ongoing controversy over the efficacy and safety of different bifurcation stenting techniques. Critical considerations are the rate of restenosis at the side branch ostium, and completeness of healing at sites of overlap of stent struts, which may affect the risk of stent thrombosis.
AIMS: To compare vessel healing at 9 months using OCT imaging for two different treatment techniques for treating bifurcation lesions. Quantitative assessment of OCT images will be used to assess re-endothelialisation and quality of strut apposition to the vessel wall.
METHODS: Patients with true bifurcation lesions with involvement of a significant side branch requiring a stent will be randomly assigned to one of two treatment strategies. Group A will comprise 20 patients which will be treated with the Axxess™ Drug Eluting Coronary Bifurcation Stent System (Biosensors Europe SA) where additional Biomatrix™ Drug Eluting Coronary Stent Systems (Biosensors Europe SA) are implanted into the distal main branch (MB) and the side branch (SB) as required. Group B will consist of 20 patients which will be treated with the culotte technique using Xience Prime everolimus-eluting stents (Abbott-Vascular, US). Kissing balloon dilatation using non-compliant balloons will complete the index procedure in all cases. At 9 months, control angiography for all patients (with QCA using dedicated software) and OCT (of both main vessel and side branch) will be performed.
ENROLMENT PLAN:
Start: Third quarter of 2011 Enrolment period: ± 12 months Clinical follow-up: 5 years Angiographic and OCT results expected third quarter of 2013
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXXESS + Biomatrix | Experimental | Device: AXXESS + Biomatrix Biolimus Eluting stentAfter mandatory predilatation, a self-expanding, conically shaped nickel-titanium AXXESS biolimus A9-eluting stent is placed at the level of the carina. The device is available in 3.0 and 3.5 mm calibre and 11 and 14 mm length. Depending on the lesion anatomy, additional Biomatrix™ Drug Eluting Coronary Stent Systems are placed distally if necessary. The procedure is completed with kissing balloon postdilatation using non-compliant balloons sized to the reference vessel diameter of the distal branches. Before this kissing balloon inflation, consecutive high pressure inflations should be performed in both branches. |
| Culotte technique: Xience V/Prime | Active comparator | Device: Culotte technique with Xience V or Xience Prime stentsThe culotte technique consists of stenting one of both branches of the bifurcation lesion first, and after balloon dilatation of the stent meshes, stenting the uncovered branch through the first stent and leaving the main vessel covered with two overlapped stents. The procedure is terminated by kissing balloon dilatation of both branches using non-compliant balloons sized to the reference vessel diameter of the distal branches. Before this kissing balloon inflation, consecutive high pressure inflations should be performed in both branches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient older than 18 years
- The subject has stable or unstable angina pectoris, or a positive functional study for ischemia.
- The subject is eligible for PCI, and is an acceptable candidate for coronary artery bypass surgery.
- The subject is male, or if female, has no childbearing potential or has had a negative urine or serum pregnancy test within 7 days of the index procedure and has no intention to become pregnant within a year of the procedure.
- The subject has signed the informed consent prior to the procedure, and agrees to comply with the follow up requirements.
Key exclusion criteria (13 listed)
- Left ventricular ejection fraction of < 30%
- Impaired renal function (serum creatinine > 2.0 mg/dl)
- Previous and/or planned brachytherapy of target vessel
- Lesion of the left main trunk > 50%, unprotected
- The target vessel contains intraluminal thrombus.
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 |
|---|---|---|
| AXXESS + Biomatrix Biolimus Eluting stentNAP | Device | AXXESS + Biomatrix |
| Culotte technique with Xience V or Xience Prime stentsNAP | Device | Culotte technique: Xience V/Prime |
Primary outcome
Primary endpoint
Time frame: 9 months
Percent uncovered to total stent struts at 9 months, assessed with OCT, in two different bifurcation stenting techniques
22 secondary outcomes
Secondary endpoint : stent strut coverage per segment with OCT
Time frame: 9 months
Secondary endpoint: stent strut apposition with OCT
Time frame: 9 months
Secondary endpoint: clusters of malapposition with OCT
Time frame: 9 months
Secondary endpoint: Tissue strut thickness with OCT
Time frame: 9 months
Secondary endpoint: neointimal hyperplasia volume
Time frame: 9 months
Secondary endpoint: late luminal loss (angiography)
Time frame: 9 months
Secondary endpoint: in-segment late luminal loss (angiography)
Time frame: 9 months
Secondary endpoint: binary restenosis (angiography)
Time frame: 9 months
Secondary endpoint: binary in-segment restenosis (angiography)
Time frame: 9 months
Secondary endpoint: minimal lumen diameter (angiography)
Time frame: 9 months
Secondary endpoints: clinical: MACE
Time frame: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoints: clinical: components of MACE: cardiac death
Time frame: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoints: clinical: components of MACE: Q- or non-Q-wave myocardial infarction
Time frame: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoints: clinical: components of MACE: clinically driven target lesion revascularization (TLR)
Time frame: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoint: Stent thrombosis
Time frame: 24h, 1 month, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: Target vessel revascularization
Time frame: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: all-cause death
Time frame: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: non-target revascularization
Time frame: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: any coronary revascularization
Time frame: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: device success
Time frame: Immediately after initial treatment of the study lesion
Secondary endpoint: lesion treatment success
Time frame: Immediately after initial treatment of the study lesion
Secondary endpoint: procedure success
Time frame: 24h after treatment of the target lesion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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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.
Christophe L Dubois, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AXXESS + Biomatrix Biolimus Eluting stent and Culotte technique with Xience V or Xience Prime stents in people with True Coronary Bifurcation Lesions, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
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 13 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: status not confirmed, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Results are not available in the source record.
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?
Primary endpoint (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2017.