Pilot Study of the Endologix Fenestrated Stent Graft System
This study is ongoing, but not recruiting participants.
Sponsor:
Endologix
Information provided by (Responsible Party):
Endologix
ClinicalTrials.gov Identifier:
NCT01437215
First received: September 17, 2011
Last updated: June 5, 2013
Last verified: June 2013
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Purpose
The purpose of this study is to determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm.
| Condition | Intervention | Phase |
|---|---|---|
|
Juxtarenal Aortic Aneurysm Pararenal Aortic Aneurysm |
Device: Ventana Fenestrated Stent Graft System |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective, Multicenter, Single Arm Feasibility and Initial Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms |
Resource links provided by NLM:
Further study details as provided by Endologix:
Primary Outcome Measures:
- Safety [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc
- Feasibility [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration
Secondary Outcome Measures:
- Safety [ Time Frame: >30 Days to 5 Years ] [ Designated as safety issue: Yes ]Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc
- Adverse Events [ Time Frame: Procedurally to 5 Years ] [ Designated as safety issue: Yes ]All adverse events, whether serious or non-serious
- Distal Blood Flow [ Time Frame: Discharge to 5 Years ] [ Designated as safety issue: Yes ]Ankle-brachial index measurements
- Renal Dysfunction [ Time Frame: Discharge to 5 Years ] [ Designated as safety issue: Yes ]eGFR reduction >30% from baseline
- Device Performance [ Time Frame: 30 Days to 5 Years ] [ Designated as safety issue: Yes ]Aortic, fenestrated, and renal stent graft integrity and patency; migration; endoleak; and aneurysm sac morphology
| Enrollment: | 15 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | August 2016 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Fenestrated Endografting |
Device: Ventana Fenestrated Stent Graft System
Endovascular repair of juxtarenal or pararenal aortic aneurysm
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed consent understood and signed and pt agrees to all follow-up visits;
- Abdominal aortic aneurysm with diameter ≥5cm or ≥4cm which has increased by 0.5cm or more in the past six months
- Adequate iliac/femoral access compatible with the required delivery systems
- Non-aneurysmal infrarenal aortic neck <15mm in length
- Most caudal renal artery to aortoiliac bifurcation length at least 70mm
- Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length at least 15 mm; angle (clock face) <60° to the aneurysm sac;
- Angle <60° (clock face) between the SMA and celiac artery
- Renal arteries both distal to the SMA by 0-35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other
- Iliac anatomy suitable for commercial bifurcated stent graft;
- Minimum 3cm overlap achievable between fenestrated and bifurcated stent grafts
Exclusion Criteria:
- Life expectancy <1 year as judged by the investigator;
- Psychiatric or other condition that may interfere with the study;
- Participating in the enrollment or 30-day follow-up phase of another clinical study;
- Known allergy to any device component;
- Coagulopathy or uncontrolled bleeding disorder;
- Contraindication to contrast media or anticoagulants;
- Ruptured, leaking, dissecting, or mycotic aneurysm;
- Serum creatinine (S-Cr) level >2.0 mg/dL;
- Traumatic vascular injury;
- Active systemic or localized groin infection;
- Connective tissue disease (e.g., Marfan's Syndrome);
- Recent (within prior three months) cerebrovascular accident or myocardial infarction;
- Prior renal transplant;
- Length of either renal artery to be stented <13mm;
- Significant occlusive disease or calcification of either renal artery;
- An essential accessory renal artery;
- Indispensable inferior mesenteric artery;
- Untreated aneurysmal disease of the descending thoracic aorta;
- Clinically significant mural thrombus circumferentially in the suprarenal segment;
- Prior iliac artery stent implanted that may interfere with delivery system introduction;
- Unsuitable vascular anatomy
- Pregnancy (female patient of childbearing potential only)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Endologix |
| ClinicalTrials.gov Identifier: | NCT01437215 History of Changes |
| Other Study ID Numbers: | CP-0002 |
| Study First Received: | September 17, 2011 |
| Last Updated: | June 5, 2013 |
| Health Authority: | Chile: Ministry of Health New Zealand: Minitry of Health |
Keywords provided by Endologix:
|
aneurysm renal stent juxtarenal pararenal |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013