Cardiovascular Disease.ASPENNCT01773148
Access Safety and Efficacy Post Endovascular Intervention
A study testing Arstasis Access System (AXERA) in people with Cardiovascular Disease., run by Arstasis, Inc. at 17 sites in United States.
Trial summary
The goal of this study is to assess the safety and effectiveness of the AXERA Access System in subjects undergoing Common Femoral Artery (CFA) access for Percutaneous Coronary Intervention (PCI) and/or Peripheral Vascular Intervention (PVI) through a 5 French (F) or 6F introducer sheath. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease.
- What is being tested?
- Arstasis Access System (AXERA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 17 sitesUnited States
- Study dates
- Dec 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years of age or older.
- Subject is clinically indicated for a PCI or PVI involving access through a 5F or 6F introducer sheath in the femoral artery.
- Subject is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) within 2 hours post procedure.
- Female subjects of child bearing potential must have a negative pregnancy test.
Who cannot join
- Subjects who are pregnant or lactating.
- Subject has a pre-existing severe non-cardiac systemic disease/illness or another reason that results in a projected life expectancy of less than 1 year.
- Subject has an active systemic or cutaneous infection or inflammation (e.g., septicemia at the time of the procedure).
- Subject has systemic hypertension unresponsive to treatment (>180mmHg systolic and >110mm diastolic).
- Subject has significant bleeding coagulopathy or platelet disorder, (INR> 2.0), including known thrombocytopenia (platelet count <100,000/µL), thrombasthenia, Von Willebrand's disease, Factor V deficiency, or anemia (hemoglobin <10 g/dL, or hematocrit <30%).
- Subject presents with chronic renal insufficiency (creatinine ≥3.0mg/dl).
Show all 20Show fewer
- Subject presents with hemodynamic instability or is in need of emergent surgery or emergent procedure.
- Subject presents with ST elevation myocardial infarction.
- Subject presents with unstable angina or non-ST elevation myocardial infarction and has troponin level > 3 X upper limit of normal. There must be at least one troponin level drawn > 6 hours after onset of chest pain.
- Subject has received low molecular weight heparin < 8 hours before vascular access, glycoprotein IIb/IIIa inhibitor < 24 hours before vascular access, unfractionated heparin by infusion < 1 hour before vascular access, or parenteral heparin at anticoagulant dose (as opposed to DVT prophylaxis)< 6 hours before vascular access.
- Subjects who are clinically obese, defined as BMI >40.
- Subject has received femoral artery Vessel Closure Implant (VCI) (suture or staple) at the target access site.
- Subject has received femoral artery VCI (collagen/PEG/PGA) at the target access site within 90 days of AXERA procedure.
- Subject is unable to routinely walk at least 20 feet without assistance (e.g., requires a walker or wheelchair to mobilize, is leg amputee or has known paralysis) or unable to ambulate within 2 hours post procedure.
- Subject has had prior vascular surgery or vascular grafts at the target femoral artery access site.
- Subject has had a previous target femoral artery complication from angiography (such as pseudoaneurysm, Arteriovenous (AV) fistula, dissection), small CFA, abnormal, absent or weak distal ipsilateral pulse, or presenting with clinically significant peripheral vascular disease in the vicinity of the puncture.
- Subject has a high puncture (i.e. above the inferior reflection of the inferior epigastric artery).
- Subject has antegrade puncture.
- Subject has a stent in the ipsilateral common femoral artery.
- Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
AnMed Health
Anderson, South Carolina, 29621
Sinai Hospital
Baltimore, Maryland, 21215
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
Heart Center Research, LLC
Huntsville, Alabama, 35801
Scripps Green
La Jolla, California, 92037
St. Rose Dominican
Las Vegas, Nevada, 89113
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Loma Linda University Health
Loma Linda, California, 92354
Medical Center of Central Georgia
Macon, Georgia, 31201
Christiana Care
Newark, Delaware, 19713
Opelousas General Health System
Opelousas, Louisiana, 70570
Mercy Heart and Vascular Institute
Sacramento, California, 95816
St. Joseph's Medical Center
Stockton, California, 95204
Franciscan Research Center
Tacoma, Washington, 98405
St. John Medical Center
Tulsa, Oklahoma, 74104
Northern Mississippi Medical Center
Tupelo, Mississippi, 38801
Lexington Medical Center
West Columbia, South Carolina, 29169
About this study
Official title: AXERA Access Safety and Efficacy Post Endovascular INtervention
The goal of this study is to assess the safety and effectiveness of the AXERA Access System in subjects undergoing Common Femoral Artery (CFA) access for Percutaneous Coronary Intervention (PCI) and/or Peripheral Vascular Intervention (PVI) through a 5 French (F) or 6F introducer sheath.
- Conditions
- Cardiovascular Disease.
- Being tested
- Arstasis Access System (AXERA)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arstasis Access System (AXERA)Device
Placement of the AXERA device in the Femoral Artery.
| Study group | Role | What they receive |
|---|---|---|
| Arstasis Access System (AXERA) placement | Experimental | Placement of AXERA device in subjects undergoing common femoral artery access for PCI and/or PVI through a 5F or 6F introducer sheath. Receives: Device: Arstasis Access System (AXERA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Events
Absence of major access site-related complications.
Measured: Procedure through 30 day follow-up.
Device Success
Defined as:
- Successful placement of AXERA followed by procedural sheath
- Achievement of hemostasis in conjunction with manual or mechanical compression
Measured: Day 1-Day of Procedure.
Secondary outcomes (5)
Time to Hemostasis (TTH)
Elapsed time between sheath removal and first observed hemostasis.
Measured: Immediately following procedural sheath removal.
Time to Ambulation (TTA)
Elapsed time between sheath removal to time when subject stands and walks at least 20 feet without re-bleeding.
Measured: Evaluated at any time after 2 hours post sheath removal, until the subject successfully ambulated.
Time to Discharge, eligibility (TTD/e)
Elapsed time between sheath removal and the time when subject is medically able to be discharged.
Measured: Evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.
Time to Discharge, actual (TTD/a)
Elapsed time between sheath removal and the actual time when subject is discharged.
Measured: Evaluated following procedural sheath removal until actual discharge.
Minor Adverse Events
Combined rate of minor vascular access-site related complications.
Measured: Procedure through 30 day follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arstasis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Dorogy, MD, Principal investigator, The Medical Center of Central Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773148
- Sponsor's protocol ID
- RC-03773
- Acronym
- ASPEN
- Status last verified
- Feb 2015
- First submitted
- 15 Jan 2013
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AXERA Access Safety and Efficacy Post Endovascular INtervention
- ClinicalTrials.gov ID
- NCT01773148
- Acronym / sponsor ID
- ASPEN / RC-03773
- Conditions
- Cardiovascular Disease.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Arstasis, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to assess the safety and effectiveness of the AXERA Access System in subjects undergoing Common Femoral Artery (CFA) access for Percutaneous Coronary Intervention (PCI) and/or Peripheral Vascular Intervention (PVI) through a 5 French (F) or 6F introducer sheath.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arstasis Access System (AXERA) placement | Experimental | Device: Arstasis Access System (AXERA)Placement of AXERA device in subjects undergoing common femoral artery access for PCI and/or PVI through a 5F or 6F introducer sheath. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is 18 years of age or older.
- Subject is clinically indicated for a PCI or PVI involving access through a 5F or 6F introducer sheath in the femoral artery.
- Subject is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) within 2 hours post procedure.
- Female subjects of child bearing potential must have a negative pregnancy test.
Key exclusion criteria (20 listed)
- Subjects who are pregnant or lactating.
- Subject has a pre-existing severe non-cardiac systemic disease/illness or another reason that results in a projected life expectancy of less than 1 year.
- Subject has an active systemic or cutaneous infection or inflammation (e.g., septicemia at the time of the procedure).
- Subject has systemic hypertension unresponsive to treatment (>180mmHg systolic and >110mm diastolic).
- Subject has significant bleeding coagulopathy or platelet disorder, (INR> 2.0), including known thrombocytopenia (platelet count <100,000/µL), thrombasthenia, Von Willebrand's disease, Factor V deficiency, or anemia (hemoglobin <10 g/dL, or hematocrit <30%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arstasis Access System (AXERA)Placement of the AXERA device in the Femoral Artery. | Device | Arstasis Access System (AXERA) placement |
Primary outcome
Major Adverse Events
Time frame: Procedure through 30 day follow-up.
Absence of major access site-related complications.
Device Success
Time frame: Day 1-Day of Procedure.
Defined as: * Successful placement of AXERA followed by procedural sheath * Achievement of hemostasis in conjunction with manual or mechanical compression
5 secondary outcomes
Time to Hemostasis (TTH)
Time frame: Immediately following procedural sheath removal.
Time to Ambulation (TTA)
Time frame: Evaluated at any time after 2 hours post sheath removal, until the subject successfully ambulated.
Time to Discharge, eligibility (TTD/e)
Time frame: Evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.
Time to Discharge, actual (TTD/a)
Time frame: Evaluated following procedural sheath removal until actual discharge.
Minor Adverse Events
Time frame: Procedure through 30 day follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
Related trials for Cardiovascular Disease.
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
RecruitingObservational study
Atrial Fibrillation Patients Treated With Catheter Ablation
Atrial Fibrillation, Atrial Fibrillation Recurrent
RecruitingPhase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
AML, Multiple Myeloma
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
RecruitingPhase 2
A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel
Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Dorogy, MD principal investigator
The Medical Center of Central Georgia
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arstasis Access System (AXERA) in people with Cardiovascular Disease., run by Arstasis, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Events (time frame: Procedure through 30 day follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2015.