Safety and Efficacy of Multiple Overlapping Uncovered Stents for Pararenal Aortic Aneurysm Repair

NCT01985906 | Unknown DMC

• 2 other identifiers: MOUS-AP080781170291
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Complex aortic aneurysms involving major branches have been difficult endovascularly. The primary purposes of this study is to evaluate the safety, feasibility, and efficacy of multiple overlapping uncovered stents in treating aortic aneurysm while preserving major visceral branches, including the celiac artery (CA), superior mesenteric artery (SMA) and renal artery (RA).

Conditions

Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic; Aortic Aneurysm, Thoracoabdominal

Keywords

Aorta; Aneurysm; Stents; Collateral Circulation

Outcome Measures

Primary Outcomes (1)

• Number of patients with aneurysm exclusion

  Aneurysm exclusion means that the aneurysm shrinks or stays stable over time.

  12 months

Secondary Outcomes (2)

• Number of patent major branches within the coverage zone

  12 months

• Number of patients with serious adverse events

  12 months

Study Arms (1)

Pararenal aortic aneurysm

EXPERIMENTAL

The aneurysm is adjacent to (proximal/distal landing zone \< 15mm) or involving vital branches, including the celiac artery, superior mesenteric artery, or renal artery. The intervention is endovascular management of the aneurysms with multiple overlapping uncovered stents

Procedure: Multiple overlapping uncovered stents; Device: Uncovered stents

Interventions

Multiple overlapping uncovered stents PROCEDURE

Endovascular management of complex aortic aneurysms with multiple overlapping uncovered stents

Pararenal aortic aneurysm

Uncovered stents DEVICE

The number of uncovered stents implanted was determined by intraoperative angiography with the criterion that a decrease of velocity in the aneurysmal sac was achieved. Side branches, including segmental arteries and visceral branches, were covered wherever necessary.

Also known as: Bare stents, Bare metal stents

Pararenal aortic aneurysm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years
• Life expectancy ≥ 12 months
• The patient or his legal representative has signed the informed consent form
• Contraindicated for open surgery, declared inoperable by surgeon and anesthetist (statement signed by each doctor) and must have at least one of the following:
• Age\>80 years
• ASA ≥3
• history of thoracic surgery or surgery of abdominal aorta
• coronary artery disease (history of angina myocardial infarction) with positive functional testing and coronary lesions for which revascularization is impossible or not indicated
• heart failure
• LVEF \< 40%
• chronic respiratory failure defined by one of the following criteria:
• FEV1 \<1.2 L/sec;
• VC \<50% of the predicted value according to age, sex and weight;
• Arterial blood gas analysis in the absence of oxygen: PaCO2\>45 mmHg or PaO2 \< 60 mmHg;
• Oxygen therapy.

You may not qualify if:

• Medical contraindications to a local or general anesthesia and angiography;
• Life expectancy less than one year, or clinical follow-up impossible;
• Congenital disorders of blood coagulation;
• Intercurrent infection;
• Allergy to aspirin, clopidogrel, or contrast agents;
• Patient (s) included in another clinical study;
• Patient pregnant or breastfeeding.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Division of Vascular Surgery, Changhai Hospital

Shanghai, 200433, China

RECRUITING

Related Publications (11)

• Zhang YX, Lu QS, Feng JX, Zhao ZQ, Bao JM, Feng R, Feng X, Jing ZP. Endovascular management of pararenal aortic aneurysms with multiple overlapping uncovered stents. J Vasc Surg. 2013 Sep;58(3):616-23. doi: 10.1016/j.jvs.2013.02.248. Epub 2013 May 25.

  PMID: 23714363 BACKGROUND

• Zhang YX, Lu QS, Jing ZP. Multilayer stents, a new progress in the endovascular treatment of aneurysms. Chin Med J (Engl). 2013 Feb;126(3):536-41.

  PMID: 23422121 BACKGROUND

• Zhang YX, Lu QS, Jing ZP. Innovative sandwich technique in treating a symptomatic saccular suprarenal aneurysm involving the celiac trunk. Vasc Endovascular Surg. 2013 Feb;47(2):102-5. doi: 10.1177/1538574412471210. Epub 2012 Dec 27.

  PMID: 23275483 BACKGROUND

• Geremia G, Haklin M, Brennecke L. Embolization of experimentally created aneurysms with intravascular stent devices. AJNR Am J Neuroradiol. 1994 Aug;15(7):1223-31.

  PMID: 7976930 BACKGROUND

• Sfyroeras GS, Dalainas I, Giannakopoulos TG, Antonopoulos K, Kakisis JD, Liapis CD. Flow-diverting stents for the treatment of arterial aneurysms. J Vasc Surg. 2012 Sep;56(3):839-46. doi: 10.1016/j.jvs.2012.04.020. Epub 2012 Jul 26.

  PMID: 22840737 BACKGROUND

• Benndorf G, Campi A, Schneider GH, Wellnhofer E, Unterberg A. Overlapping stents for treatment of a dissecting carotid artery aneurysm. J Endovasc Ther. 2001 Dec;8(6):566-70. doi: 10.1177/152660280100800605.

  PMID: 11797969 BACKGROUND

• Hurst RW, Haskal ZJ, Zager E, Bagley LJ, Flamm ES. Endovascular stent treatment of cervical internal carotid artery aneurysms with parent vessel preservation. Surg Neurol. 1998 Oct;50(4):313-7; discussion 317. doi: 10.1016/s0090-3019(97)00461-8.

  PMID: 9817452 BACKGROUND

• Klein GE, Szolar DH, Raith J, Fruhwirth H, Pascher O, Hausegger KA. Posttraumatic extracranial aneurysm of the internal carotid artery: combined endovascular treatment with coils and stents. AJNR Am J Neuroradiol. 1997 Aug;18(7):1261-4.

  PMID: 9282852 BACKGROUND

• Uchino H, Asano T, Nakayama N, Kuroda S, Houkin K. [Flow diversion by double-overlapping-stent for fusiform vertebral artery aneurysm: a case report]. No Shinkei Geka. 2011 Jan;39(1):59-63. Japanese.

  PMID: 21270480 BACKGROUND

• Ruiz-Juretschke F, Castro E, Mateo Sierra O, Iza B, Manuel Garbizu J, Fortea F, Villoria F. Massive epistaxis resulting from an intracavernous internal carotid artery traumatic pseudoaneurysm: complete resolution with overlapping uncovered stents. Acta Neurochir (Wien). 2009 Dec;151(12):1681-4. doi: 10.1007/s00701-009-0294-5. Epub 2009 Apr 7.

  PMID: 19350203 BACKGROUND

• Ozturk MH, Eyuboglu I, Pulathan Z, Dinc H. Spontaneous thrombosis of a saccular iliac artery aneurysm induced by overlapping self-expandable bare metallic stents. Diagn Interv Radiol. 2010 Dec;16(4):308-11. doi: 10.4261/1305-3825.DIR.2422-08.0. Epub 2009 Oct 19.

  PMID: 19838982 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic; Aortic Aneurysm, Thoracoabdominal; Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Qingsheng Lu, MD

  Changhai Hospital

  STUDY CHAIR

• Yongxue Zhang, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingsheng Lu, MD

CONTACT

+86 021 31161662; vascsurg.ch@xueguan.net

Yongxue Zhang, MD

CONTACT

+86 13671856162; zhangyx0807@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 18, 2013
• Study Start: May 1, 2014
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

CN (1)