Heart DiseasePhase 4NCT00178672
A Single Center of Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease
A Phase 4 study testing Angioguard XP distal protection device, Heart Catheterization -Angioplasty and stenting in people with Heart Disease and Brain Vascular Accident, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The primary objective of this study is to assess the safety and effectiveness of stenting in the treatment of obstructive carotid artery disease. Secondary objectives are the assessment and standardization of optimal operator techniques and successful deployment and retrieval of the AngioGuard XP Distal Protection… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Brain Vascular Accident, Carotid Artery Disease
- What is being tested?
- Angioguard XP distal protection device, Heart Catheterization -Angioplasty and stenting
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Aug 2007
- Phase
- Phase 4
- 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
- The patient must be > 18 years of age.
- The patient must be clinically symptomatic, i.e., within the previous 120 days have experienced in the ipsilateral carotid artery distribution, either 1) one or more TIAs, characterized by distinct focal neurologic dysfunction or monocular blindness with clearing of signs and symptoms within 24 hours, or 2) one or more completed strokes (as defined by this protocol) with persistence of symptoms or signs for more than 24 hours (the most recent event is used as the qualifying event). Except as excluded below, the patient must have documented stenosis > 60%, of the common or internal carotid artery. For an asymptomatic patient to be considered, the patient must have a > 70% diameter stenosis of the internal or common carotid artery without neurological symptoms.
- An angiogram is required to qualify the patient, it should be as recent as feasible and will not be acceptable if done > 120 days from study entry.
- An ultrasound will be used as a screening procedure for potential eligible patients and will be performed less than 30 days prior to study entry.
- Stenosis >50%: PSV>130 cm/sec; EDV <135 cm/sec
- Stenosis >80%: PSV>220 cm/sec; EDV ³135 cm/sec
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- PSV ICA/PSV CCA ratio ³ 4.011
- The stenosis must be of presumed atherosclerotic origin or secondary to restenosis after previous endarterectomy.
- The target lesion may be in the native common or internal carotid artery
- Temporary cardiac pacing of the patient must be possible, if necessary, along with any necessary hemodynamic support such as vasopressor agents or hemodynamic monitoring.
- Patients taking warfarin may be included if their dosage is reduced before the procedure to result in an INR of 1.5 or less and a Prothrombin Time of 15 seconds. Warfarin may be restarted after the procedure.
- Female patients of childbearing potential must have a documented negative pregnancy test during the index hospitalization because exposure to the radiation and the drugs (antiplatelet agents, anticoagulant agents) given during the cath lab procedure would be potentially harmful to an unborn fetus.
- The patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board or Medical Ethics Committee.
Who cannot join
- Candidates will be excluded from the study if ANY of the following conditions apply:
- The patient has had an intracranial hemorrhage, hemorrhagic stroke, major stroke, or any stroke with mass effect demonstrated on CT scan or MRI within four weeks of the index procedure.
- The patient has an intracranial mass lesion
- The patient has an ipsilateral intracranial or extracranial arterial stenosis greater in severity than the treatment lesion.
- The patient has known allergies to heparin, to both ticlopidine and clopidogrel or to metals used in stents.
- The patient has a history of prior life-threatening reaction to the radiocontrast agent.
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- The patient has peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding use of catheter-based techniques required for successful results.
- Femoral access is not possible.
- The patient, if female, has a positive pregnancy test
- The patient has any intracranial aneurysm (> 6 mm).
- The patient has an arterio-venous malformation in the territory of the target carotid artery.
- The patient has unstable angina or evolving MI. .
- The patient has a history of bleeding diathesis or coagulopathy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Hospital/ Unversity of Texas -HSC Houston
Houston, Texas, 77030
About this study
Official title: A Single Center IDE Study on Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease
The primary objective of this study is to assess the safety and effectiveness of stenting in the treatment of obstructive carotid artery disease. Secondary objectives are the assessment and standardization of optimal operator techniques and successful deployment and retrieval of the AngioGuard XP Distal Protection Device. This is a single center, prospective, open-label feasibility study. The study population will consist of patients with atherosclerotic obstructive or post-endarterectomy restenotic lesions in native carotid arteries. The intention is to include patients with both types of lesions.
Read the detailed description
This study is a single center, prospective, open-label feasibility study evaluating the safety and effectiveness of Carotid Stenting. The study population will include patients with atherosclerotic obstructive lesions and/or post-endarterectomy restenotic obstructive lesions in native carotid arteries. The intention is to include patients with both types of lesions.
At the 30-day, 6-month and 1-year post-procedure clinical visits, the procedures will include a neurological examination and an evaluation of any adverse events. A carotid ultrasound will be performed at 6 months and 1 year after the procedure.
Guidelines for stopping the study will be event rates such as stroke and death that exceed twice the expected frequency of such events treated by surgical endarterectomy techniques. The control rates utilized will be drawn from the NASCET Trial.
Patients who meet all the inclusion criteria and none of the exclusion criteria (as specified in sections 4.1 and 4.2 respectively) will be offered the choice of participating in this study. . Within the inclusion/exclusion criteria are included patients who would otherwise be at high risk for surgical endarterectomy. This would include patients with restenosis after endarterectomy, radical neck dissection, contralateral carotid artery occlusion, and high take-off carotid bifurcation disease. Since 1989, 8000 carotid artery stent procedures have been performed worldwide with a success rate of 98.6%. This procedure combined with the distal protection device, is predicted to show an even greater success rate and a decrease in adverse events for these patients. For these reasons, any patient with significant carotid artery disease felt to be at high risk for surgical correction will be offered the chance to enroll in this registry.
The patients are referred by the stroke team and also by vascular surgery. The potential risks, including recent stroke, excessive cardiopulmonary risk, last remaining patent vessel, etc are all considered as well as the risks of traditional medical or surgical therapy. All treatment options along with possible risks and benefits will be extensively discussed. Cases are reviewed by a multidisciplinary team at a scheduled conference. It is determined at that time whether the patient may be a candidate for carotid stenting. If all criteria are met, then the procedure and study as well as other options will be explained to the patient. An extensive discussion will occur with the patient and family regarding all potential treatment options, risks, and benefits. If the patient wishes to proceed with carotid stenting and be included in the study, an office visit is made with the investigator if not previously done and a possible procedure date is set after the visit with the investigator. At the office visit, the study and informed consent will be explained. All questions will be answered and the patient, if he wishes, will agree to the study by signing the informed consent. The patient and family will be given phone numbers to call for any additional concerns or questions and are repeatedly encouraged to contact us for any arising concerns both before and after the procedure.
- Being tested
- Angioguard XP distal protection device, Heart Catheterization -Angioplasty, stenting
- Keywords
- CVA, TIA, Carotid disease, Stroke, Neurology, Carotid Stenting
- Medical subject headings
- Heart Diseases, Stroke, Carotid Artery Diseases, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioguard XP distal protection deviceDevice
Standard of care stenting of carotid arteries protocol is used.
Heart Catheterization -AngioplastyProcedure or surgery
Standard of care carotid stenting. A catheter is inserted in the femoral vein into the carotid artery where a balloon is inflated and shortly thereafter a stent is placed in the target lesion area.
stentingDevice
stenting of carotid arteries
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day composite of major adverse clinical events including death, any stroke, and/or myocardial infarction
Measured: 1-30 days
Secondary outcomes (5)
successful stent deployment at the target lesion in a variety of carotid morphologies
Measured: 30 minutes to 1 hour
,successful filter deployment and retrieval
Measured: 30 minutes to 1 hour
,<30% residual stenosis determined by angiography immediately post-stent placement
Measured: 30 minutes to 1 hour
,access site vascular complications, such as need for surgical repair or blood transfusion
Measured: 30 minutes to 1 hour
,patency (< 50% restenosis) of the stent as determined by carotid ultrasound imaging at six (6) months .
Measured: 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2002
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Investigators
- Richard W Smalling, MD,PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178672
- Sponsor's protocol ID
- HSC-MS 01-269 Single Center
- Status last verified
- Nov 2020
- First submitted
- 13 Sep 2005
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center IDE Study on Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease
- ClinicalTrials.gov ID
- NCT00178672
- Acronym / sponsor ID
- HSC-MS 01-269 Single Center
- Keywords
- CVA, TIA, Carotid disease, Stroke, Neurology, Carotid Stenting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Nov 2002
- Study completion
- Aug 2007 (actual)
- First posted
- 15 Sep 2005 (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 primary objective of this study is to assess the safety and effectiveness of stenting in the treatment of obstructive carotid artery disease. Secondary objectives are the assessment and standardization of optimal operator techniques and successful deployment and retrieval of the AngioGuard XP Distal Protection Device. This is a single center, prospective, open-label feasibility study. The study population will consist of patients with atherosclerotic obstructive or post-endarterectomy restenotic lesions in native carotid arteries. The intention is to include patients with both types of lesions.
Detailed description
This study is a single center, prospective, open-label feasibility study evaluating the safety and effectiveness of Carotid Stenting. The study population will include patients with atherosclerotic obstructive lesions and/or post-endarterectomy restenotic obstructive lesions in native carotid arteries. The intention is to include patients with both types of lesions.
At the 30-day, 6-month and 1-year post-procedure clinical visits, the procedures will include a neurological examination and an evaluation of any adverse events. A carotid ultrasound will be performed at 6 months and 1 year after the procedure.
Guidelines for stopping the study will be event rates such as stroke and death that exceed twice the expected frequency of such events treated by surgical endarterectomy techniques. The control rates utilized will be drawn from the NASCET Trial.
Patients who meet all the inclusion criteria and none of the exclusion criteria (as specified in sections 4.1 and 4.2 respectively) will be offered the choice of participating in this study. . Within the inclusion/exclusion criteria are included patients who would otherwise be at high risk for surgical endarterectomy. This would include patients with restenosis after endarterectomy, radical neck dissection, contralateral carotid artery occlusion, and high take-off carotid bifurcation disease. Since 1989, 8000 carotid artery stent procedures have been performed worldwide with a success rate of 98.6%. This procedure combined with the distal protection device, is predicted to show an even greater success rate and a decrease in adverse events for these patients. For these reasons, any patient with significant carotid artery disease felt to be at high risk for surgical correction will be offered the chance to enroll in this registry.
The patients are referred by the stroke team and also by vascular surgery. The potential risks, including recent stroke, excessive cardiopulmonary risk, last remaining patent vessel, etc are all considered as well as the risks of traditional medical or surgical therapy. All treatment options along with possible risks and benefits will be extensively discussed. Cases are reviewed by a multidisciplinary team at a scheduled conference. It is determined at that time whether the patient may be a candidate for carotid stenting. If all criteria are met, then the procedure and study as well as other options will be explained to the patient. An extensive discussion will occur with the patient and family regarding all potential treatment options, risks, and benefits. If the patient wishes to proceed with carotid stenting and be included in the study, an office visit is made with the investigator if not previously done and a possible procedure date is set after the visit with the investigator. At the office visit, the study and informed consent will be explained. All questions will be answered and the patient, if he wishes, will agree to the study by signing the informed consent. The patient and family will be given phone numbers to call for any additional concerns or questions and are repeatedly encouraged to contact us for any arising concerns both before and after the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The patient must be > 18 years of age.
- The patient must be clinically symptomatic, i.e., within the previous 120 days have experienced in the ipsilateral carotid artery distribution, either 1) one or more TIAs, characterized by distinct focal neurologic dysfunction or monocular blindness with clearing of signs and symptoms within 24 hours, or 2) one or more completed strokes (as defined by this protocol) with persistence of symptoms or signs for more than 24 hours (the most recent event is used as the qualifying event). Except as excluded below, the patient must have documented stenosis > 60%, of the common or internal carotid artery. For an asymptomatic patient to be considered, the patient must have a > 70% diameter stenosis of the internal or common carotid artery without neurological symptoms.
- An angiogram is required to qualify the patient, it should be as recent as feasible and will not be acceptable if done > 120 days from study entry.
- An ultrasound will be used as a screening procedure for potential eligible patients and will be performed less than 30 days prior to study entry.
- The stenosis must be of presumed atherosclerotic origin or secondary to restenosis after previous endarterectomy.
Key exclusion criteria (13 listed)
- The patient has had an intracranial hemorrhage, hemorrhagic stroke, major stroke, or any stroke with mass effect demonstrated on CT scan or MRI within four weeks of the index procedure.
- The patient has an intracranial mass lesion
- The patient has an ipsilateral intracranial or extracranial arterial stenosis greater in severity than the treatment lesion.
- The patient has known allergies to heparin, to both ticlopidine and clopidogrel or to metals used in stents.
- The patient has a history of prior life-threatening reaction to the radiocontrast agent.
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 |
|---|---|---|
| Angioguard XP distal protection deviceStandard of care stenting of carotid arteries protocol is used. | Device | – |
| Heart Catheterization -AngioplastyStandard of care carotid stenting. A catheter is inserted in the femoral vein into the carotid artery where a balloon is inflated and shortly thereafter a stent is placed in the target lesion area. | Procedure or surgery | – |
| stentingstenting of carotid arteries | Device | – |
Primary outcome
30-day composite of major adverse clinical events including death, any stroke, and/or myocardial infarction
Time frame: 1-30 days
5 secondary outcomes
successful stent deployment at the target lesion in a variety of carotid morphologies
Time frame: 30 minutes to 1 hour
,successful filter deployment and retrieval
Time frame: 30 minutes to 1 hour
,<30% residual stenosis determined by angiography immediately post-stent placement
Time frame: 30 minutes to 1 hour
,access site vascular complications, such as need for surgical repair or blood transfusion
Time frame: 30 minutes to 1 hour
,patency (< 50% restenosis) of the stent as determined by carotid ultrasound imaging at six (6) months .
Time frame: 6 months post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- The University of Texas Health Science Center web siteLink provided by the sponsor.
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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.
Richard W Smalling, MD,PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angioguard XP distal protection device, Heart Catheterization -Angioplasty and stenting in people with Heart Disease and Brain Vascular Accident, run by The University of Texas Health Science Center, Houston at 1 site 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 13 inclusion and 13 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: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30-day composite of major adverse clinical events including death, any stroke, and/or myocardial infarction (time frame: 1-30 days). 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 5 Nov 2020.