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

Primary Purpose

Aortic Aneurysm, Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Multiple overlapping uncovered stents

Uncovered stents

About this trial

This is an interventional treatment trial for Aortic Aneurysm focused on measuring Aorta, Aneurysm, Stents, Collateral Circulation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
1. Age>80 years
2. ASA ≥3
3. history of thoracic surgery or surgery of abdominal aorta
4. coronary artery disease (history of angina myocardial infarction) with positive functional testing and coronary lesions for which revascularization is impossible or not indicated
5. heart failure
6. LVEF < 40%
7. chronic respiratory failure defined by one of the following criteria:
  1. FEV1 <1.2 L/sec;
  2. VC <50% of the predicted value according to age, sex and weight;
  3. Arterial blood gas analysis in the absence of oxygen: PaCO2>45 mmHg or PaO2 < 60 mmHg;
  4. Oxygen therapy.
8. renal insufficiency if creatininaemia> 200 micromol/L before injection of contrast product;
9. hostile abdomen, including presence of ascites or other signs of portal hypertension;
10. obesity.
Conventional tubular stent-graft is not suitable due to complicated aneurysm anatomy, such as being adjacent to (proximal or distal landing zone < 15mm) or involving vital branches, including the celiac artery, superior mesenteric artery, or renal artery.
Adequate arterial anatomy of aneurismal lesion access.

Exclusion Criteria:

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.

Sites / Locations

Division of Vascular Surgery, Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pararenal aortic aneurysm

Arm Description

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

Outcomes

Primary Outcome Measures

Number of patients with aneurysm exclusion

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

Secondary Outcome Measures

Number of patent major branches within the coverage zone

Major branches include the celiac artery, superior mesenteric artery, or renal artery.

Number of patients with serious adverse events

Adverse events include aneurysm-related, procedure-related, and stent-related complications or mortality

Full Information

NCT ID

NCT01985906

First Posted

November 7, 2013

Last Updated

May 5, 2014

Sponsor

Changhai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01985906

Brief Title

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

Acronym

SEMPER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Unknown status

Study Start Date

May 2014 (undefined)

Primary Completion Date

October 2020 (Anticipated)

Study Completion Date

October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

The traditional endovascular treatment of aneurysms is based on the utilization of stent-grafts that create a mechanical barrier between the aneurysmal sac and normal blood flow. Problems such as endoleak and occlusion of collateral arteries impede its application in complex aneurysms adjacent to or involving vital branches. Advanced branched/fenestrated endografts have been applied in many experienced centers, but the application of these techniques is limited in less-experienced centers due to the complicated and cumbersome nature of these procedures. The concept of using bare metal stents to occlude aneurysms was firstly described about two decades ago. Geremia et al suggested that a metallic stent bridging a saccular aneurysm would alter the local flow pattern, promoting thrombus formation, thereby leading to aneurysm occlusion. Optimal flow modulation effect is reached with a mean stent porosity of 65%. To achieve such low mesh porosity while maintaining the flexibility of the stent, the investigators applied multiple stents in an overlapping fashion. Computational simulation in this study has demonstrated that with 3 or 4 bare metal stents deployed, the mesh porosity could be decreased to an effective value, slowing flow velocity within the sac. The use of overlapping stents has been reported in the treatment of peripheral aneurysms with satisfactory clinical outcome. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Aorta, Aneurysm, Stents, Collateral Circulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pararenal aortic aneurysm

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Multiple overlapping uncovered stents

Intervention Description

Endovascular management of complex aortic aneurysms with multiple overlapping uncovered stents

Intervention Type

Device

Intervention Name(s)

Uncovered stents

Other Intervention Name(s)

Bare stents, Bare metal stents

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of patients with aneurysm exclusion

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Number of patent major branches within the coverage zone

Description

Major branches include the celiac artery, superior mesenteric artery, or renal artery.

Time Frame

12 months

Title

Number of patients with serious adverse events

Description

Adverse events include aneurysm-related, procedure-related, and stent-related complications or mortality

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. renal insufficiency if creatininaemia> 200 micromol/L before injection of contrast product; hostile abdomen, including presence of ascites or other signs of portal hypertension; obesity. Conventional tubular stent-graft is not suitable due to complicated aneurysm anatomy, such as being adjacent to (proximal or distal landing zone < 15mm) or involving vital branches, including the celiac artery, superior mesenteric artery, or renal artery. Adequate arterial anatomy of aneurismal lesion access. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qingsheng Lu, MD

Phone

+86 021 31161662

vascsurg.ch@xueguan.net

First Name & Middle Initial & Last Name or Official Title & Degree

Yongxue Zhang, MD

Phone

+86 13671856162

zhangyx0807@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qingsheng Lu, MD

Organizational Affiliation

Changhai Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Yongxue Zhang, MD

Organizational Affiliation

Changhai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Vascular Surgery, Changhai Hospital

City

Shanghai

ZIP/Postal Code

200433

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qingsheng Lu, MD

Phone

+86 021 31161662

vascsurg.ch@xueguan.net

First Name & Middle Initial & Last Name & Degree

Yongxue Zhang, MD

Phone

+86 13671856162

zhangyx0807@yahoo.com

First Name & Middle Initial & Last Name & Degree

Yongxue Zhang, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

23714363

Citation

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.

Results Reference

background

PubMed Identifier

23422121

Citation

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.

Results Reference

background

PubMed Identifier

23275483

Citation

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.

Results Reference

background

PubMed Identifier

7976930

Citation

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.

Results Reference

background

PubMed Identifier

22840737

Citation

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.

Results Reference

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PubMed Identifier

11797969

Citation

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.

Results Reference

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PubMed Identifier

9817452

Citation

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.

Results Reference

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PubMed Identifier

9282852

Citation

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.

Results Reference

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PubMed Identifier

21270480

Citation

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.

Results Reference

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PubMed Identifier

19350203

Citation

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.

Results Reference

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PubMed Identifier

19838982

Citation

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.

Results Reference

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

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