Aortic Aneurysm of the Proximal ArchNCT00488696
Branched Aortic Arch Study
A study testing Endovascular Bifurcated Stent-Graft in people with Aortic Aneurysm of the Proximal Arch, run by Timothy Chuter, MD at 1 site in United States.
Trial summary
This is a study to assess the safety and effectiveness of endovascular treatment of aortic aneurysms involving the proximal aortic arch. The investigational operation involves placing a stent-graft over the aortic aneurysm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm of the Proximal Arch
- What is being tested?
- Endovascular Bifurcated Stent-Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2025
- 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
- Aneurysm of the aortic arch larger than 6cm in diameter, or symptomatic aneurysm of the aortic arch, of any diameter, or any arch aneurysm with a 2-year rupture rate estimated to be more than 20%.
- Anticipated mortality rate with open repair estimated to be more than 20%.
- Suitable arterial anatomy for stent-graft
- Life expectancy more than 2 years
- Ability to give informed consent and willingness to comply with follow-up schedule
Who cannot join
- Free rupture of the aneurysm
- Pregnancy
- Anaphylactic reaction to contrast material
- Allergy to stainless steel or polyester
- Unwillingness or inability to comply with the follow-up schedule
- Serious systemic or groin infection
Show all 9Show fewer
- Uncorrectable coagulopathy
- Significant presence of carotid artery atherosclerosis
- Arrhythmia define as 2nd- and 3rd-degree atrioventricular block or sinus node disease, such as sick sinus syndrome and symptomatic bradycardia, unless the patient already has a pacemaker in place and cardiology consultation confirms that it is safe to proceed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Division of Vascular and Endovascular Surgery
San Francisco, California, 94143
About this study
Official title: Branched Stent-Graft Repair for Endo Repair of Aneurysms Involving the Proximal Aortic Arch
This is a study to assess the safety and effectiveness of endovascular treatment of aortic aneurysms involving the proximal aortic arch. The investigational operation involves placing a stent-graft over the aortic aneurysm.
Read the detailed description
An aneurysm is a localized bulge in the wall of an artery. Aneurysms of the aorta are prone to progressive dilatation, which if left untreated ultimately results in rupture, internal bleeding and death. Traditional open surgery involves aortic exposure through a long incision, aortic clamping to interrupt blood flow, and replacement or repair of the dilated aortic segment using a fabric conduit (graft), which is sutured (anastomosis) to the nondilated arteries above and below the aneurysm. Some subjects are able to withstand such a large operation better than others, but many suffer complications, and all suffer pain, debility, and a lengthy stay in hospital.
Endovascular aneurysm repair is a less invasive alternative that substitutes a trans-arterial route to the aneurysm for direct exposure, and stent-mediated attachment for sutured anastomosis. Compared to open surgical repair, endovascular repair is associated with less physiological derangement, less pain, less blood loss, lower complication rates and shorter hospital stay. Consequently, endovascular repair has become standard therapy for aneurysms of the abdominal aorta and descending thoracic aorta, where there are no vital branches and endovascular exclusion rarely causes ischemic complications.
Open surgical repair of the proximal aortic arch requires hypothermic circulatory arrest, because it deprives the heart of its outflow and the brain of its inflow. Endovascular repair also obstructs outflow from the heart, but only for a few seconds, while the graft is released from its delivery sheath. The greater problem is inflow to the brain. In anticipation of aortic arch exclusion, the brachiocephalic circulation requires an alternative source of blood. One alternative is bypass from the ascending aorta. However, this requires median sternotomy and partial aortic clamping, both of with are potential sources of morbidity.
- Conditions
- Aortic Aneurysm of the Proximal Arch
- Being tested
- Endovascular Bifurcated Stent-Graft
- Keywords
- Aneurysm, Aortic Arch, Endovascular, Stent-Graft
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Bifurcated Stent-GraftDevice
Treatment of Aneurysm involving the proximal aortic arch with endovascular bifurcated stent-graft.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Endovascular Bifurcated Stent Graft: The investigational operation involves placing a stent-graft over the aortic aneurysm. Receives: Device: Endovascular Bifurcated Stent-Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful implantation of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch
Measured: 1 month
Secondary outcomes (1)
Stability of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startOct 2006
- Primary completionDec 2024 (estimated)
- Study completionSep 2025
Why it stopped: The study team was unable to identify eligible subjects. The study is being closed out due to a lack of subject eligibility. Zero subjects were enrolled in the entire duration of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm of the Proximal ArchStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy Chuter, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Timothy Chuter, MD, University of California, San Francisco
- Investigators
- Linda M Reilly, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488696
- Sponsor's protocol ID
- 10-03930
- Status last verified
- Dec 2025
- First submitted
- 18 Jun 2007
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Svensson LG, Crawford ES, Hess KR, Coselli JS, Raskin S, Shenaq SA, Safi HJ. Deep hypothermia with circulatory arrest. Determinants of stroke and early mortality in 656 patients. J Thorac Cardiovasc Surg. 1993 Jul;106(1):19-28; discussion 28-31.
PubMed 8321002Ergin MA, Griepp EB, Lansman SL, Galla JD, Levy M, Griepp RB. Hypothermic circulatory arrest and other methods of cerebral protection during operations on the thoracic aorta. J Card Surg. 1994 Sep;9(5):525-37. doi: 10.1111/j.1540-8191.1994.tb00886.x.
PubMed 7994095Criado FJ, Barnatan MF, Rizk Y, Clark NS, Wang CF. Technical strategies to expand stent-graft applicability in the aortic arch and proximal descending thoracic aorta. J Endovasc Ther. 2002 Jun;9 Suppl 2:II32-8.
PubMed 12166839Saccani S, Nicolini F, Beghi C, Marcato C, Uccelli M, Larini P, Budillon AM, Agostinelli A, Gherli T. Thoracic aortic stents: a combined solution for complex cases. Eur J Vasc Endovasc Surg. 2002 Nov;24(5):423-7. doi: 10.1053/ejvs.2002.1687.
PubMed 12435342Chuter TA, Buck DG, Schneider DB, Reilly LM, Messina LM. Development of a branched stent-graft for endovascular repair of aortic arch aneurysms. J Endovasc Ther. 2003 Oct;10(5):940-5. doi: 10.1177/152660280301000517.
PubMed 14656176Schneider DB, Curry TK, Reilly LM, Kang JW, Messina LM, Chuter TA. Branched endovascular repair of aortic arch aneurysm with a modular stent-graft system. J Vasc Surg. 2003 Oct;38(4):855. doi: 10.1016/s0741-5214(03)01024-3. No abstract available.
PubMed 14560244
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Branched Stent-Graft Repair for Endo Repair of Aneurysms Involving the Proximal Aortic Arch
- ClinicalTrials.gov ID
- NCT00488696
- Acronym / sponsor ID
- 10-03930
- Conditions
- Aortic Aneurysm of the Proximal Arch
- Keywords
- Aneurysm, Aortic Arch, Endovascular, Stent-Graft
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study team was unable to identify eligible subjects. The study is being closed out due to a lack of subject eligibility. Zero subjects were enrolled in the entire duration of the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Timothy Chuter, MDUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Sep 2025 (actual)
- First posted
- 20 Jun 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.
This is a study to assess the safety and effectiveness of endovascular treatment of aortic aneurysms involving the proximal aortic arch. The investigational operation involves placing a stent-graft over the aortic aneurysm.
Detailed description
An aneurysm is a localized bulge in the wall of an artery. Aneurysms of the aorta are prone to progressive dilatation, which if left untreated ultimately results in rupture, internal bleeding and death. Traditional open surgery involves aortic exposure through a long incision, aortic clamping to interrupt blood flow, and replacement or repair of the dilated aortic segment using a fabric conduit (graft), which is sutured (anastomosis) to the nondilated arteries above and below the aneurysm. Some subjects are able to withstand such a large operation better than others, but many suffer complications, and all suffer pain, debility, and a lengthy stay in hospital.
Endovascular aneurysm repair is a less invasive alternative that substitutes a trans-arterial route to the aneurysm for direct exposure, and stent-mediated attachment for sutured anastomosis. Compared to open surgical repair, endovascular repair is associated with less physiological derangement, less pain, less blood loss, lower complication rates and shorter hospital stay. Consequently, endovascular repair has become standard therapy for aneurysms of the abdominal aorta and descending thoracic aorta, where there are no vital branches and endovascular exclusion rarely causes ischemic complications.
Open surgical repair of the proximal aortic arch requires hypothermic circulatory arrest, because it deprives the heart of its outflow and the brain of its inflow. Endovascular repair also obstructs outflow from the heart, but only for a few seconds, while the graft is released from its delivery sheath. The greater problem is inflow to the brain. In anticipation of aortic arch exclusion, the brachiocephalic circulation requires an alternative source of blood. One alternative is bypass from the ascending aorta. However, this requires median sternotomy and partial aortic clamping, both of with are potential sources of morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Endovascular Bifurcated Stent-GraftEndovascular Bifurcated Stent Graft: The investigational operation involves placing a stent-graft over the aortic aneurysm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aneurysm of the aortic arch larger than 6cm in diameter, or symptomatic aneurysm of the aortic arch, of any diameter, or any arch aneurysm with a 2-year rupture rate estimated to be more than 20%.
- Anticipated mortality rate with open repair estimated to be more than 20%.
- Suitable arterial anatomy for stent-graft
- Life expectancy more than 2 years
- Ability to give informed consent and willingness to comply with follow-up schedule
Key exclusion criteria (9 listed)
- Free rupture of the aneurysm
- Pregnancy
- Anaphylactic reaction to contrast material
- Allergy to stainless steel or polyester
- Unwillingness or inability to comply with the follow-up schedule
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 |
|---|---|---|
| Endovascular Bifurcated Stent-GraftTreatment of Aneurysm involving the proximal aortic arch with endovascular bifurcated stent-graft. | Device | Interventional |
Primary outcome
Successful implantation of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch
Time frame: 1 month
1 secondary outcome
Stability of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 8321002Svensson LG, Crawford ES, Hess KR, Coselli JS, Raskin S, Shenaq SA, Safi HJ. Deep hypothermia with circulatory arrest. Determinants of stroke and early mortality in 656 patients. J Thorac Cardiovasc Surg. 1993 Jul;106(1):19-28; discussion 28-31.
- Background: PubMed 7994095Ergin MA, Griepp EB, Lansman SL, Galla JD, Levy M, Griepp RB. Hypothermic circulatory arrest and other methods of cerebral protection during operations on the thoracic aorta. J Card Surg. 1994 Sep;9(5):525-37. doi: 10.1111/j.1540-8191.1994.tb00886.x.
- Background: PubMed 12166839Criado FJ, Barnatan MF, Rizk Y, Clark NS, Wang CF. Technical strategies to expand stent-graft applicability in the aortic arch and proximal descending thoracic aorta. J Endovasc Ther. 2002 Jun;9 Suppl 2:II32-8.
- Background: PubMed 12435342Saccani S, Nicolini F, Beghi C, Marcato C, Uccelli M, Larini P, Budillon AM, Agostinelli A, Gherli T. Thoracic aortic stents: a combined solution for complex cases. Eur J Vasc Endovasc Surg. 2002 Nov;24(5):423-7. doi: 10.1053/ejvs.2002.1687.
- Background: PubMed 14656176Chuter TA, Buck DG, Schneider DB, Reilly LM, Messina LM. Development of a branched stent-graft for endovascular repair of aortic arch aneurysms. J Endovasc Ther. 2003 Oct;10(5):940-5. doi: 10.1177/152660280301000517.
- Background: PubMed 14560244Schneider DB, Curry TK, Reilly LM, Kang JW, Messina LM, Chuter TA. Branched endovascular repair of aortic arch aneurysm with a modular stent-graft system. J Vasc Surg. 2003 Oct;38(4):855. doi: 10.1016/s0741-5214(03)01024-3. No abstract available.
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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.
Linda M Reilly, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Bifurcated Stent-Graft in people with Aortic Aneurysm of the Proximal Arch, run by Timothy Chuter, MD 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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 16 Dec 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Successful implantation of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch (time frame: 1 month). 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 NCT00488696, which also lists 6 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 16 Dec 2025.