Descending Thoracic Aortic DiseaseGore ThoracicNCT00546312
Clinical Study of Thoracic Excluder Endoprosthesis to Treat Descending Thoracic Aortic Diseases
A study testing Thoracic EXCLUDER Endoprosthesis in people with Descending Thoracic Aortic Disease, run by Arizona Heart Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of endovascular repair, using the Thoracic EXCLUDER Endoprosthesis, when used in the treatment of descending thoracic aortic disease as indicated by radiological testing at time of discharge, and 1, 6, 12 months and annually following implantation, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Descending Thoracic Aortic Disease
- What is being tested?
- Thoracic EXCLUDER Endoprosthesis
- Type of treatment
- Medical device
- How many people
- 332 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to Jun 2012
- 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
- Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transections.
- Anatomy meets Thoracic EXCLUDER Endoprosthesis specification criteria.
- Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm.
- < 60 angle in the aortic arch may require additional length of non- aneurysmal segment if the arch is included in the treatment segment.
- The patient is of a "high risk" status for surgical repair. The patient is characterized by the presence of co-morbid factors and/or thoracic aortic pathology that place the patient in a category of prohibitive risk for open repair, and, without intervention, and adverse event could be anticipated within days or weeks. The patient has an ASA score of IV or V.
- Ability to comply with protocol requirements including follow-up.
- Signed Informed Consent Form.
Who cannot join
- > 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta.
- Significant thrombus at the proximal or distal implantation sites.
- Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit provided.
- Myocardial infarction within six weeks.
- Degenerative connective tissue disease, e.g. Marfan's or Ehler Danlos Syndrome, unless the proximal and distal implantation sites of the Thoracic EXCLUDER Endoprosthesis are located within previously placed surgical grafts.
- Female of child bearing potential with positive pregnancy test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Evaluating Use of the Thoracic EXCLUDER Endoprosthesis in the Treatment of Descending Thoracic Aortic Diseases
The purpose of this study is to evaluate the safety and efficacy of endovascular repair, using the Thoracic EXCLUDER Endoprosthesis, when used in the treatment of descending thoracic aortic disease as indicated by radiological testing at time of discharge, and 1, 6, 12 months and annually following implantation, and to determine the proportion of patients who experience adverse events during and after the implantation procedure, including disease-specific and overall mortality rates.
Read the detailed description
Thoracic aortic aneurysm, while relatively rare, is a potentially lethal disorder with a poor long-term prognosis if not treated. As the aortic diameter increases, wall tension becomes higher, leading to further expansion of the aneurysm. Consequently, this disease process is a "progressive and self propagating" phenomena, and the natural history of the disease is progressive expansion of the aneurysm with eventual rupture. Patients with descending thoracic aortic aneurysms frequently have concomitant major medical conditions, making them poor candidates for major surgical procedures. Concomitant conditions may include: hypertension, chronic obstructive pulmonary disease, congestive heart failure, and peripheral vascular disease, including abdominal aortic aneurysm, previous stroke and peripheral arterial occlusive disease.
The accepted treatment for aneurysms deemed to warrant intervention is surgical resection and repair. Operative and post operative complications contributing to early mortality after surgical repair of descending thoracic aortic aneurysms include low cardiac output, pulmonary insufficiency, myocardial infarction, postoperative hemorrhage, pulmonary embolism and sepsis.
In addition to mortality, two of the gravest complications of this surgical procedure, neurologic complications due to spinal cord ischemia, such as paraplegia and paraparesis, and renal failure or dysfunction, remain common.
Dissections, another disease process of the descending thoracic aorta, are rare. Aortic dissections are thought to start with a tear or disruption of the intimal lining of the aorta, either due to medial degenerative diseases, trauma or rupture of an ulcerated intimal plaque. Blood at systemic arterial pressures invades the underlying medial layer of the aortic wall, dissecting the layers of the aortic wall, and forming a false lumen. The dissection then propagates for varying distances and in varying directions along the length of the aorta.
As the false lumen increases in size, arterial flow to the true aortic lumen and to arteries arising from the aorta may be blocked or disrupted. Depending upon the location of the primary intimal tear and the direction of dissection propagation, various vital organs may loose arterial blood supply, and the aorta may rupture into the pericardial sac or pleural space, leading to cardiac tamponade or free pleural rupture. Blood flow from the false lumen may reenter the true lumen through another intimal tear, which may occur proximal or distal to the first, depending on the direction of dissection propagation.
Medical therapy is the first line treatment for dissections of the descending thoracic aorta, and is aimed at reducing the mean, peak and diastolic recoil arterial pressure and the dP/dt while maintaining sufficient pressure to adequately perfuse all vital organs. Surgical intervention is warranted for patients with progression of dissection, impending rupture, refractory hypertension, a sizable localized false aneurysmal component, or continued pain.
A device has been designed to treat disease processes of the descending thoracic aorta. The Thoracic EXCLUDER Endoprosthesis is a device that allows for primary endovascular repair of the descending thoracic aorta and is intended to be used as an intraluminal blood conduit. The Thoracic EXCLUDER Endoprosthesis is a flexible, self-expanding endoprosthesis that is constrained on the leading end of a delivery catheter. A separate balloon catheter, the Thoracic EXCLUDER Balloon Catheter, is used to smooth the endoprosthesis following implantation.
Subjects will undergo an evaluation of the endoprosthesis, and will also be evaluated for device and procedure related adverse events that may have occurred during the follow-up period. Follow-up will be completed at 1, 3, 6, 12, 24, 36, 48, and 60 months. Subject evaluation at 1 and 3 months will include a complete Physical Examination and a CT with contrast enhancement. Subject evaluation at 6, 12, 24, 36, 48, and 60 months will also undergo a complete Physical Examination, a CT with contrast enhancement, and a Chest X-Ray (AP, Lateral, and 2 obliques).
- Conditions
- Descending Thoracic Aortic Disease
- Being tested
- Thoracic EXCLUDER Endoprosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic EXCLUDER EndoprosthesisDevice
Stent-graft endoprosthesis is inserted by Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Successful completion of the treatment at the initial time of the procedure defined by successful access to the arterial system, deployment, placement and patency of the Thoracic TAG Endoprosthesis at time of procedure.
Measured: following procedure
Treatment Success
Initial technical success and exclusion of the appropriate portion of the descending thoracic aortic disease from the blood circulation, defined as the absence of aneurysm enlargement (if aneurysm present) and avoidance of rupture, without major complications within 30 days of the procedure.
Measured: 30 days
Clinical Success
Treatment success followed by patency of the graft, and continued exclusion of the appropriate portion of the descending thoracic aortic disease from the blood circulation, without reintervention, rupture, and any major complications through twelve months.
Measured: through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
- Study startFeb 2000
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Descending Thoracic Aortic 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
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona Heart Institute
- Sponsor type
- University, hospital or other
- Investigators
- Edward B Diethrich, M.D., Principal investigator, Arizona Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546312
- Sponsor's protocol ID
- G990299
- Acronym
- Gore Thoracic
- Status last verified
- May 2009
- First submitted
- 16 Oct 2007
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Fann JI, Miller DC. Endovascular treatment of descending thoracic aortic aneurysms and dissections. Surg Clin North Am. 1999 Jun;79(3):551-74. doi: 10.1016/s0039-6109(05)70024-4.
PubMed 10410687Bickerstaff LK, Pairolero PC, Hollier LH, Melton LJ, Van Peenen HJ, Cherry KJ, Joyce JW, Lie JT. Thoracic aortic aneurysms: a population-based study. Surgery. 1982 Dec;92(6):1103-8.
PubMed 7147188Clouse WD, Hallett JW Jr, Schaff HV, Gayari MM, Ilstrup DM, Melton LJ 3rd. Improved prognosis of thoracic aortic aneurysms: a population-based study. JAMA. 1998 Dec 9;280(22):1926-9. doi: 10.1001/jama.280.22.1926.
PubMed 9851478McNamara JJ, Pressler VM. Natural history of arteriosclerotic thoracic aortic aneurysms. Ann Thorac Surg. 1978 Nov;26(5):468-73. doi: 10.1016/s0003-4975(10)62927-x.
PubMed 753161Najafi H. 1980: descending aortic aneurysmectomy without adjuncts to avoid ischemia. 1993 update. Ann Thorac Surg. 1993 Apr;55(4):1042-5. doi: 10.1016/0003-4975(93)90150-g.
PubMed 8466324von Segesser LK, Killer I, Jenni R, Lutz U, Turina MI. Improved distal circulatory support for repair of descending thoracic aortic aneurysms. Ann Thorac Surg. 1993 Dec;56(6):1373-80. doi: 10.1016/0003-4975(93)90684-a.
PubMed 8267439Hamerlijnck RP, Rutsaert RR, De Geest R, Brutel de la Riviere A, Defauw JJ, Vermeulen FE. Surgical correction of descending thoracic aortic aneurysms under simple aortic cross-clamping. J Vasc Surg. 1989 Apr;9(4):568-73.
PubMed 2709524Culliford AT, Ayvaliotis B, Shemin R, Colvin SB, Isom OW, Spencer FC. Aneurysms of the descending aorta. Surgical experience in 48 patients. J Thorac Cardiovasc Surg. 1983 Jan;85(1):98-104.
PubMed 6848892Carlson DE, Karp RB, Kouchoukos NT. Surgical treatment of aneurysms of the descending thoracic aorta: an analysis of 85 patients. Ann Thorac Surg. 1983 Jan;35(1):58-69. doi: 10.1016/s0003-4975(10)61432-4.
PubMed 6849582Cooley DA, Baldwin RT. Technique of open distal anastomosis for repair of descending thoracic aortic aneurysms. Ann Thorac Surg. 1992 Nov;54(5):932-6. doi: 10.1016/0003-4975(92)90652-k.
PubMed 1417289Dake MD, Miller DC, Mitchell RS, Semba CP, Moore KA, Sakai T. The
Borst HG, Jurmann M, Buhner B, Laas J. Risk of replacement of descending aorta with a standardized left heart bypass technique. J Thorac Cardiovasc Surg. 1994 Jan;107(1):126-32; discussion 132-3.
PubMed 8283874Lawrie GM, Earle N, De Bakey ME. Evolution of surgical techniques for aneurysms of the descending thoracic aorta: twenty-nine years experience with 659 patients. J Card Surg. 1994 Nov;9(6):648-61. doi: 10.1111/j.1540-8191.1994.tb00899.x.
PubMed 7841645Laschinger JC, Izumoto H, Kouchoukos NT. Evolving concepts in prevention of spinal cord injury during operations on the descending thoracic and thoracoabdominal aorta. Ann Thorac Surg. 1987 Dec;44(6):667-74. doi: 10.1016/s0003-4975(10)62163-7.
PubMed 3318742Rutherford RB; editor; Vascular Surgery, Fourth Edition; 1995, W. B. Saunders Co.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating Use of the Thoracic EXCLUDER Endoprosthesis in the Treatment of Descending Thoracic Aortic Diseases
- ClinicalTrials.gov ID
- NCT00546312
- Acronym / sponsor ID
- Gore Thoracic / G990299
- Conditions
- Descending Thoracic Aortic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Arizona Heart InstituteUniversity, hospital or other
- Study start
- Feb 2000
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 18 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of endovascular repair, using the Thoracic EXCLUDER Endoprosthesis, when used in the treatment of descending thoracic aortic disease as indicated by radiological testing at time of discharge, and 1, 6, 12 months and annually following implantation, and to determine the proportion of patients who experience adverse events during and after the implantation procedure, including disease-specific and overall mortality rates.
Detailed description
Thoracic aortic aneurysm, while relatively rare, is a potentially lethal disorder with a poor long-term prognosis if not treated. As the aortic diameter increases, wall tension becomes higher, leading to further expansion of the aneurysm. Consequently, this disease process is a "progressive and self propagating" phenomena, and the natural history of the disease is progressive expansion of the aneurysm with eventual rupture. Patients with descending thoracic aortic aneurysms frequently have concomitant major medical conditions, making them poor candidates for major surgical procedures. Concomitant conditions may include: hypertension, chronic obstructive pulmonary disease, congestive heart failure, and peripheral vascular disease, including abdominal aortic aneurysm, previous stroke and peripheral arterial occlusive disease.
The accepted treatment for aneurysms deemed to warrant intervention is surgical resection and repair. Operative and post operative complications contributing to early mortality after surgical repair of descending thoracic aortic aneurysms include low cardiac output, pulmonary insufficiency, myocardial infarction, postoperative hemorrhage, pulmonary embolism and sepsis.
In addition to mortality, two of the gravest complications of this surgical procedure, neurologic complications due to spinal cord ischemia, such as paraplegia and paraparesis, and renal failure or dysfunction, remain common.
Dissections, another disease process of the descending thoracic aorta, are rare. Aortic dissections are thought to start with a tear or disruption of the intimal lining of the aorta, either due to medial degenerative diseases, trauma or rupture of an ulcerated intimal plaque. Blood at systemic arterial pressures invades the underlying medial layer of the aortic wall, dissecting the layers of the aortic wall, and forming a false lumen. The dissection then propagates for varying distances and in varying directions along the length of the aorta.
As the false lumen increases in size, arterial flow to the true aortic lumen and to arteries arising from the aorta may be blocked or disrupted. Depending upon the location of the primary intimal tear and the direction of dissection propagation, various vital organs may loose arterial blood supply, and the aorta may rupture into the pericardial sac or pleural space, leading to cardiac tamponade or free pleural rupture. Blood flow from the false lumen may reenter the true lumen through another intimal tear, which may occur proximal or distal to the first, depending on the direction of dissection propagation.
Medical therapy is the first line treatment for dissections of the descending thoracic aorta, and is aimed at reducing the mean, peak and diastolic recoil arterial pressure and the dP/dt while maintaining sufficient pressure to adequately perfuse all vital organs. Surgical intervention is warranted for patients with progression of dissection, impending rupture, refractory hypertension, a sizable localized false aneurysmal component, or continued pain.
A device has been designed to treat disease processes of the descending thoracic aorta. The Thoracic EXCLUDER Endoprosthesis is a device that allows for primary endovascular repair of the descending thoracic aorta and is intended to be used as an intraluminal blood conduit. The Thoracic EXCLUDER Endoprosthesis is a flexible, self-expanding endoprosthesis that is constrained on the leading end of a delivery catheter. A separate balloon catheter, the Thoracic EXCLUDER Balloon Catheter, is used to smooth the endoprosthesis following implantation.
Subjects will undergo an evaluation of the endoprosthesis, and will also be evaluated for device and procedure related adverse events that may have occurred during the follow-up period. Follow-up will be completed at 1, 3, 6, 12, 24, 36, 48, and 60 months. Subject evaluation at 1 and 3 months will include a complete Physical Examination and a CT with contrast enhancement. Subject evaluation at 6, 12, 24, 36, 48, and 60 months will also undergo a complete Physical Examination, a CT with contrast enhancement, and a Chest X-Ray (AP, Lateral, and 2 obliques).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transections.
- Anatomy meets Thoracic EXCLUDER Endoprosthesis specification criteria.
- Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm.
- The patient is of a "high risk" status for surgical repair. The patient is characterized by the presence of co-morbid factors and/or thoracic aortic pathology that place the patient in a category of prohibitive risk for open repair, and, without intervention, and adverse event could be anticipated within days or weeks. The patient has an ASA score of IV or V.
- Ability to comply with protocol requirements including follow-up.
Key exclusion criteria (6 listed)
- > 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta.
- Significant thrombus at the proximal or distal implantation sites.
- Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit provided.
- Myocardial infarction within six weeks.
- Degenerative connective tissue disease, e.g. Marfan's or Ehler Danlos Syndrome, unless the proximal and distal implantation sites of the Thoracic EXCLUDER Endoprosthesis are located within previously placed surgical grafts.
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 |
|---|---|---|
| Thoracic EXCLUDER EndoprosthesisStent-graft endoprosthesis is inserted by Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator. | Device | – |
Primary outcome
Technical success
Time frame: following procedure
Successful completion of the treatment at the initial time of the procedure defined by successful access to the arterial system, deployment, placement and patency of the Thoracic TAG Endoprosthesis at time of procedure.
Treatment Success
Time frame: 30 days
Initial technical success and exclusion of the appropriate portion of the descending thoracic aortic disease from the blood circulation, defined as the absence of aneurysm enlargement (if aneurysm present) and avoidance of rupture, without major complications within 30 days of the procedure.
Clinical Success
Time frame: through 12 months
Treatment success followed by patency of the graft, and continued exclusion of the appropriate portion of the descending thoracic aortic disease from the blood circulation, without reintervention, rupture, and any major complications through twelve months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
- Background: PubMed 10410687Fann JI, Miller DC. Endovascular treatment of descending thoracic aortic aneurysms and dissections. Surg Clin North Am. 1999 Jun;79(3):551-74. doi: 10.1016/s0039-6109(05)70024-4.
- Background: PubMed 7147188Bickerstaff LK, Pairolero PC, Hollier LH, Melton LJ, Van Peenen HJ, Cherry KJ, Joyce JW, Lie JT. Thoracic aortic aneurysms: a population-based study. Surgery. 1982 Dec;92(6):1103-8.
- Background: PubMed 9851478Clouse WD, Hallett JW Jr, Schaff HV, Gayari MM, Ilstrup DM, Melton LJ 3rd. Improved prognosis of thoracic aortic aneurysms: a population-based study. JAMA. 1998 Dec 9;280(22):1926-9. doi: 10.1001/jama.280.22.1926.
- Background: PubMed 753161McNamara JJ, Pressler VM. Natural history of arteriosclerotic thoracic aortic aneurysms. Ann Thorac Surg. 1978 Nov;26(5):468-73. doi: 10.1016/s0003-4975(10)62927-x.
- Background: PubMed 8466324Najafi H. 1980: descending aortic aneurysmectomy without adjuncts to avoid ischemia. 1993 update. Ann Thorac Surg. 1993 Apr;55(4):1042-5. doi: 10.1016/0003-4975(93)90150-g.
- Background: PubMed 8267439von Segesser LK, Killer I, Jenni R, Lutz U, Turina MI. Improved distal circulatory support for repair of descending thoracic aortic aneurysms. Ann Thorac Surg. 1993 Dec;56(6):1373-80. doi: 10.1016/0003-4975(93)90684-a.
- Background: PubMed 2709524Hamerlijnck RP, Rutsaert RR, De Geest R, Brutel de la Riviere A, Defauw JJ, Vermeulen FE. Surgical correction of descending thoracic aortic aneurysms under simple aortic cross-clamping. J Vasc Surg. 1989 Apr;9(4):568-73.
- Background: PubMed 6848892Culliford AT, Ayvaliotis B, Shemin R, Colvin SB, Isom OW, Spencer FC. Aneurysms of the descending aorta. Surgical experience in 48 patients. J Thorac Cardiovasc Surg. 1983 Jan;85(1):98-104.
- Background: PubMed 6849582Carlson DE, Karp RB, Kouchoukos NT. Surgical treatment of aneurysms of the descending thoracic aorta: an analysis of 85 patients. Ann Thorac Surg. 1983 Jan;35(1):58-69. doi: 10.1016/s0003-4975(10)61432-4.
- Background: PubMed 1417289Cooley DA, Baldwin RT. Technique of open distal anastomosis for repair of descending thoracic aortic aneurysms. Ann Thorac Surg. 1992 Nov;54(5):932-6. doi: 10.1016/0003-4975(92)90652-k.
- BackgroundDake MD, Miller DC, Mitchell RS, Semba CP, Moore KA, Sakai T. The
- Background: PubMed 8283874Borst HG, Jurmann M, Buhner B, Laas J. Risk of replacement of descending aorta with a standardized left heart bypass technique. J Thorac Cardiovasc Surg. 1994 Jan;107(1):126-32; discussion 132-3.
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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.
Edward B Diethrich, M.D. principal investigator
Arizona Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic EXCLUDER Endoprosthesis in people with Descending Thoracic Aortic Disease, run by Arizona Heart Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 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 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Technical success (time frame: following procedure). 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 NCT00546312, which also lists 21 linked publications.
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 27 May 2010.