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

May 5, 2014 updated by: Qingsheng Lu, MD, Changhai Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Recruiting
        • Division of Vascular Surgery, Changhai Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yongxue Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pararenal aortic aneurysm

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
Endovascular management of complex aortic aneurysms with multiple overlapping uncovered stents
Device: Uncovered stents
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.
Other Names:
  • Bare stents
  • Bare metal stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with aneurysm exclusion
Time Frame: 12 months
Aneurysm exclusion means that the aneurysm shrinks or stays stable over time.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patent major branches within the coverage zone
Time Frame: 12 months
Major branches include the celiac artery, superior mesenteric artery, or renal artery.
12 months
Number of patients with serious adverse events
Time Frame: 12 months
Adverse events include aneurysm-related, procedure-related, and stent-related complications or mortality
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Study Chair: Qingsheng Lu, MD, Changhai Hospital
  • Principal Investigator: Yongxue Zhang, MD, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

November 7, 2013

First Submitted That Met QC Criteria

November 10, 2013

First Posted (Estimate)

November 18, 2013

Study Record Updates

Last Update Posted (Estimate)

May 6, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOUS-AP0807
  • 81170291 (Other Grant/Funding Number: National Natural Science Foundation of China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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