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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Changhai Hospital
Sponsor:
Information provided by (Responsible Party):
Qingsheng Lu, MD, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT01985906
First received: November 7, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
Aortic Aneurysm, Thoracoabdominal
Procedure: Multiple overlapping uncovered stents
Device: Uncovered stents

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of Multiple Overlapping Uncovered Stents for Endovascular Pararenal Aortic Aneurysm Repair

Resource links provided by NLM:


Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • Number of patients with aneurysm exclusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Aneurysm exclusion means that the aneurysm shrinks or stays stable over time.


Secondary Outcome Measures:
  • Number of patent major branches within the coverage zone [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Major branches include the celiac artery, superior mesenteric artery, or renal artery.

  • Number of patients with serious adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Adverse events include aneurysm-related, procedure-related, and stent-related complications or mortality


Estimated Enrollment: 50
Study Start Date: May 2014
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985906

Contacts
Contact: Qingsheng Lu, MD +86 021 31161662 vascsurg.ch@xueguan.net
Contact: Yongxue Zhang, MD +86 13671856162 zhangyx0807@yahoo.com

Locations
China
Division of Vascular Surgery, Changhai Hospital Recruiting
Shanghai, China, 200433
Contact: Qingsheng Lu, MD    +86 021 31161662    vascsurg.ch@xueguan.net   
Contact: Yongxue Zhang, MD    +86 13671856162    zhangyx0807@yahoo.com   
Principal Investigator: Yongxue Zhang, MD         
Sponsors and Collaborators
Changhai Hospital
Investigators
Study Chair: Qingsheng Lu, MD Changhai Hospital
Principal Investigator: Yongxue Zhang, MD Changhai Hospital
  More Information

Publications:

Responsible Party: Qingsheng Lu, MD, Associate Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT01985906     History of Changes
Other Study ID Numbers: MOUS-AP0807, 81170291
Study First Received: November 7, 2013
Last Updated: May 5, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Changhai Hospital:
Aorta
Aneurysm
Stents
Collateral Circulation

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 22, 2014