WISE: Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting

• Sponsor: Gardia Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01783639
• Collaborator: (none)
• Enrollment: 120
• Locations: 10
• Arm: 1
• Duration (Months): 25.9
• Patients Per Site: 12
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with embolic protection studies

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Diseases; Stroke	Procedure: Carotid Artery Stent	N/A

Detailed Description

Patient registry procedures include:

• Clinical Events Committee (CEC); responsibility for validating all reported primary safety outcomes

• Data Safety Monitoring Board (DSMB); to review and evaluate safety data including serious adverse events

• 100% data monitoring; to compare data entered into the registry

• Source data verification; to assess the accuracy, completeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms).

• Standard Operating Procedures; to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis and reporting for adverse events.

• Sample size assessment to specify the number of participants and follow up duration.

• Data Management Plan; to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results

• Statistical analysis plan; describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The WISE Study is a Pivotal Study Evaluating the Safety and Performance of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Device: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent	Procedure: Carotid Artery Stent; Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices

Outcome Measures

Primary Outcome Measures

1. The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction. [Within 30 Days of procedure]

   Each participant will be followed for 30 days of procedure during which the number of major cardiac and cerebral adverse events (Stroke, Death and Myocardial Infraction) will be counted to evaluate the device safety.

Secondary Outcome Measures

1. The Rate of Device Success [Participants will be followed for the duration of the procedure, an expected average of 35 minutes]

   Defined as a successful delivery, deployment and retrieval of WIRION™ without any complications

2. The Rate of Clinical Success [Participants will be followed for the duration of the procedure, an expected average of 35 minutes]

   Defined as freedom from procedure related serious adverse events

3. The Rate of Access Site Complications [Within 30 Days of procedure]

4. Neurological Events Occurring Within 30 Days Post Procedure,Including Strokes and Transient Ischemic Attacks [Within 30 Days of procedure]

5. Angiographic Success [Participants will be followed for the duration of the procedure, an expected average of 35 minutes]

   Successful completion of the protected stent procedure without angiographic complications

6. Procedural Success [Participants will be followed for the duration of the procedure, an expected average of 35 minutes]

   Defined as both device and angiographic success

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years of age

• Anticipated patient life expectancy of at least 1 year

• Patient or authorized representative, signed a written Informed Consent form

• Patient is willing to comply with the protocol requirements

• Candidate for catheter-based therapy of a single stenosis located in the internal carotid artery (ICA) or the carotid bifurcation, suitable for treatment with a single FDA-approved stent with a carotid use indication

• Reference vessel diameter for intended filter location between 3.5mm and 6.0mm

• An adequate "landing zone" of at least 30mm

• Patients with severe symptomatic or asymptomatic carotid artery stenosis, to be ≥ 50% for symptomatic patients OR ≥ 80% for asymptomatic patients

• At least one high surgical risk criteria, either anatomical or co-morbid risk factors, as listed below:

Category I - Anatomical high risk factors

• Recurrent stenosis after endarterectomy

• Previous radical neck surgery or radiation therapy to the neck

• High cervical ICA lesions or CCA lesions at or above C2 or below the clavicle

• Spinal immobility of the neck

• Tracheostomy or tracheal stoma

• Any laryngeal nerve palsy and bilateral carotid artery stenosis

Category II - Co-morbid risk factors

• Contralateral carotid occlusion

• Unstable angina (Canadian Cardiovascular Society class III/IV)

• Congestive Heart Failure (New York Heart Association functional class III/IV) and/or known severe left ventricular dysfunction LVEF<30%

• Requires coronary artery bypass surgery, cardiac valve surgery, major vascular surgery, or abdominal aortic aneurysm repair 31-60 days post carotid stent procedure

• Recent MI (>72 hr and <4 weeks)

• Severe pulmonary disease with FEV1 of <30%

• CAD in ≥2 unrevascularized vessels with stenosis ≥70%

• Age ≥75 years

• Uncontrolled diabetes - Female patient with no child bearing potential or has negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study

Exclusion Criteria:

• Total occlusion or near-occlusion of the target vessel

• Severe lesion calcification

• Presence of an alternate source of emboli

• Presence of a filling defect, or angiographically visible thrombus, at target site

• A greater than 50% CCA lesion proximal to the target or a distal (intracranial) lesion more severe than the target lesion

• Evolving, acute or recent stroke within the last 30 days

• Major stroke with a residual neurological deficit that would confound neurologic assessment

• Vertebrobasilar insufficiency symptoms only

• Major operation 30 days before or after the index procedure

• Ipsilateral intracranial stenosis that requires treatment

• Any pre-existing stent in ipsilateral carotid artery, or placement of a stent in contralateral carotid within 30 days of the index procedure

• History of intracranial hemorrhage within 12 months

• Any condition that precludes proper angiographic assessment or prevents femoral arterial access

• Uncontrolled hypertension

• Contraindication to heparin and bivalirudin, aspirin, thienopyridines

• Known sensitivity to radiographic contrast media which cannot be controlled with pre-medication

• History or current indication of bleeding diathesis or coagulopathy

• Chronic renal insufficiency

• Carotid artery dissection or aortic arch anatomical anomalies

• Dementia or a neurological illness

• Patient is enrolled in another drug or device study protocol that has not reached its primary endpoint

• Severe pulmonary hypertension

• Intra-cranial pathology (e.g., tumor, AVM. aneurysm, etc) that would make study participation inappropriate or confound neurologic assessment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Sint Blasius Hospital, Department of Vascular Surgery	Dendermonde		Belgium	9200
2	Universitaets Herzzentrum	Bad-Krozingen		Germany	79189
3	Ihre-Radiologen.de	Berlin		Germany	13347
4	Klinikum Dortmund GmbH	Dortmund		Germany	44137
5	CardioVascular Center Frankfurt	Frankfurt		Germany	60389
6	Hamburg University Cardiovascular Center	Hamburg		Germany	22527
7	Herzzentrum and Park-Krankenhaus	Leipzig		Germany	04289
8	Städtisches Klinikum München GmbH Klinikum Neuperlach	Munich		Germany	87137
9	Villa Maria Cecilia Hospital	Cotignola		Italy	48010
10	Mirano Hospital	Mirano		Italy	30035

Sponsors and Collaborators

• Gardia Medical

Investigators

• Principal Investigator: Dierk Scheinert, MD, Herzzentrum Leipzig GmbH and Park-Krankenhaus Leipzig
• Principal Investigator: Horst Sievert, MD, Cardio Vascular Center Frankfurt
• Principal Investigator: Stefan Rohde, MD, Radiologische Klinik, Klinikum Dortmund GmbH
• Principal Investigator: Joachim Schofer, MD, Universitäres Herz- und Gefäßzentrum Hamburg
• Principal Investigator: Harald Mudra, MD, Städtisches Klinikum München GmbH
• Principal Investigator: Marc Bosiers, MD, AZ St-Blasius, Dendermonde
• Principal Investigator: Thomas Zeller, MD, Universitaets Herzzentrum, Bad-Krozingen
• Principal Investigator: Alberto Cremonesi, MD, Villa Maria Cecilia, Contignola
• Principal Investigator: Bernhard Reimers, MD, Mirano Hospital
• Principal Investigator: Henrik Schröder, MD, Ihre-Radiologen.de

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gardia Medical
• ClinicalTrials.gov Identifier: NCT01783639
• Other Study ID Numbers: WIRION™ Pivotal Study (WISE); WIRION Study Europe (WISE)
• First Posted: Feb 5, 2013
• Last Update Posted: Aug 7, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by Gardia Medical: Carotid; Carotid artery stenting; Stent; Embolic protection; Atherosclerotic Disease
• Additional relevant MeSH terms: Carotid Artery Diseases

Study Results

Participant Flow

Arm/Group Title	WIRION
Arm/Group Description	Device: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices
Period Title: Overall Study
STARTED	120
COMPLETED	120
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Arm 1
Arm/Group Description	Device: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices
Overall Participants	120
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	13 10.8%
>=65 years	107 89.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.9 (8.0)
Sex: Female, Male (Count of Participants)
Female	33 27.5%
Male	87 72.5%
Region of Enrollment (participants) [Number]
Belgium	11 9.2%
Italy	40 33.3%
Germany	69 57.5%

Outcome Measures

1. Primary Outcome

Title	The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction.
Description	Each participant will be followed for 30 days of procedure during which the number of major cardiac and cerebral adverse events (Stroke, Death and Myocardial Infraction) will be counted to evaluate the device safety.
Time Frame	Within 30 Days of procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description	Device: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices
Measure Participants	120
Number (95% Confidence Interval) [participants]	4 3.3%

2. Secondary Outcome

Title	The Rate of Device Success
Description	Defined as a successful delivery, deployment and retrieval of WIRION™ without any complications
Time Frame	Participants will be followed for the duration of the procedure, an expected average of 35 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	The Rate of Clinical Success
Description	Defined as freedom from procedure related serious adverse events
Time Frame	Participants will be followed for the duration of the procedure, an expected average of 35 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	The Rate of Access Site Complications
Time Frame	Within 30 Days of procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Neurological Events Occurring Within 30 Days Post Procedure,Including Strokes and Transient Ischemic Attacks
Time Frame	Within 30 Days of procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Angiographic Success
Description	Successful completion of the protected stent procedure without angiographic complications
Time Frame	Participants will be followed for the duration of the procedure, an expected average of 35 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Procedural Success
Description	Defined as both device and angiographic success
Time Frame	Participants will be followed for the duration of the procedure, an expected average of 35 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	WIRION
Arm/Group Description	Device: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices
All Cause Mortality
	WIRION
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	WIRION
	Affected / at Risk (%)	# Events
Total	18/120 (15%)
Blood and lymphatic system disorders
Low hemoglobin level	2/120 (1.7%)	2
Cardiac disorders
Cardiovascular	4/120 (3.3%)	4
Gastrointestinal disorders
Severe anemia related to gastrointestinal bleeding	1/120 (0.8%)	1
General disorders
Admission at hospital with pain in segment L5/S1, protrusion of intervertebral discs	1/120 (0.8%)	1
Incomplete occulomoric paresis because of hypotension	1/120 (0.8%)	1
Macular artery occlusion	1/120 (0.8%)	1
Hospitalization due to aphasia and worsening of general health	1/120 (0.8%)	1
Nervous system disorders
Neurological/ Nervous system	7/120 (5.8%)	7
Other (Not Including Serious) Adverse Events
	WIRION
	Affected / at Risk (%)	# Events
Total	0/120 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.