RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)

• Sponsor: Cardiva Medical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01297322
• Collaborator: (none)
• Enrollment: 420
• Locations: 21
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 20
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva

VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis:

The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA) results that are less than manual compression by a clinically meaningful and statistically significant margin. The rate of major access site-related complications with the Cardiva VASCADE™ VCS is non-inferior to the major complication rates of manual compression for sealing femoral arterial access sites.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound	Other: Manual compression; Device: Cardiva VASCADE™ Vascular Closure System	N/A

Detailed Description

A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing femoral arterial access sites and providing reduced times to hemostasis and ambulation compared with manual compression at the completion of diagnostic or interventional endovascular procedures performed through 6 Fr or 7 Fr introducer sheaths. Subjects will be randomized in a 2:1 treatment device to control ratio.

Study Design

• Study Type: Interventional
• Actual Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Prospective, Randomized, Controlled, Trial to Evaluate the Safety and Efficacy of the Cardiva VASCADE VCS vs. Manual Compression for the Management of the Femoral Arteriotomy After Percutaneous Endovascular Procedures
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Manual compression Using manual compression to reach hemostasis	Other: Manual compression; Standard of Care
Experimental: VASCADE™ Vascular Closure System The Cardiva VASCADETM Vascular Closure System (VCS) is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular catheterization procedures utilizing 6 Fr or 7 Fr procedural sheaths.	Device: Cardiva VASCADE™ Vascular Closure System; Investigational Hemostatic Vascular Closure System

Outcome Measures

Primary Outcome Measures

1. Time to Hemostasis (TTH) [Up to 1 hour]

   Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.

2. Rate of Combined Access Site-related Major Complications [30 days +/- 7 days]

   Primary safety endpoint Access site-related bleeding requiring transfusion; Vascular injury requiring repair (via surgery, ultrasound guided compression, transcatheter embolization or stent graft); New ipsilateral lower extremity ischemia causing a threat to the viability of the limb and requiring surgical or additional percutaneous intervention. This compromised blood flow is documented by subject symptoms, physical exam and/or a decreased or absent blood flow on lower extremity angiogram.; Access site-related infection requiring intravenous antibiotics and/or extended hospitalization; New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair; Permanent access site-related nerve injury. (> 30 days)

Secondary Outcome Measures

1. Time to Ambulation (TTA) [Up to 1 day]

   Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding

2. Time to Discharge Eligibility (TTDE) [Up to 2 days]

   Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is medically able to be discharged based solely on the assessment of the access site, as determined by the medical team

3. Time to Hospital Discharge (TTHD) [Up to 2 days]

   Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is actually discharged from the hospital

4. Device Success [Up to 1 day]

   Secondary effectiveness endpoint - ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with VASCADE alone or with adjunctive compression

5. Procedure Success [30 days +/- 7 days]

   Secondary effectiveness endpoint - attainment of final hemostasis using any method and freedom from major vascular complications through 30 days

6. Rate of Combined Minor Access Site Complications [30 days +/- 7 days]

   Secondary safety endpoint Access site-related bleeding requiring greater than 30 minutes to achieve hemostasis; Access site-related hematoma > 6 cm; Late access site-related bleeding (following hospital discharge); Ipsilateral lower extremity arterial emboli; Ipsilateral deep vein thrombosis; Access site-related vessel laceration; Access site wound dehiscence; Localized access site infection treated with intramuscular or oral antibiotics; Arteriovenous fistula not requiring treatment; Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection; Pseudoaneurysm not requiring treatment; New onset access site-related neuropathy in the ipsilateral lower extremity not requiring surgical repair; Ipsilateral pedal pulse diminished by two grades or transiently lost.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Pre-Operative Inclusion Criteria:

• Patients undergoing an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 6 or 7 Fr introducer sheath

Pre-Operative Exclusion Criteria:

1. Advanced refusal of blood transfusion, if necessary;

2. Active systemic or a cutaneous infection or inflammation;

3. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;

4. Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);

5. Severe co-existing morbidities having a life expectancy of less than 30 days;

6. Currently involved in any other investigational clinical trial;

7. Ipsilateral femoral arteriotomy within the previous 30 days;

8. Planned endovascular procedure within the next 30 days;

9. Previous ipsilateral femoral artery closure using a permanent implant-based closure device;

10. Previous vascular grafts or surgery at the target vessel access site;

11. History of symptomatic peripheral arterial disease, revascularization or deep vein thrombosis in the ipsilateral limb;

12. Unilateral or bilateral lower extremity amputation(s);

13. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;

14. Renal insufficiency (serum creatinine of > 2.5 mg/dl);

15. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;

16. Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2);

17. Unable to routinely walk at least 20 feet without assistance (see protocol);

18. Known allergy/adverse reaction to bovine derivatives, sodium hyaluronate or hyaluronan preparations;

19. Procedures that extend hospitalization (e.g., staged endovascular procedure, CABG);

20. Administration of low molecular weight heparin (LMWH) within 8 hours of the procedure.

Intra-op Exclusion Criteria

1. An introducer sheath with an overall length greater than 11 cm, or not 6 Fr or 7 Fr diameter;

2. Femoral artery diameter less than 6 mm at access site;

3. Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, "back wall stick", etc.);

4. Angiographic evidence of more than minimal calcium, atherosclerotic disease, or stent within 1 cm of the puncture site;

5. Overlapping Common Femoral Vein and Femoral Artery at access site;

6. Placement of ipsilateral venous sheath during procedure;

7. Arterial access site located not at common femoral artery (e.g., on or below the bifurcation, above the lower border of the inferior epigastric artery, or above the pelvic brim);

8. More than one access site required;

9. Loss of distal pulses in the ipsilateral extremity during the procedure;

10. Subjects receiving unfractionated heparin with an ACT greater than 300 seconds in the absence of a glycoprotein IIb/IIIa inhibitor or greater than 250 seconds in the presence of a glycoprotein IIb/IIIa inhibitor (may wait to remove introducer sheath until ACT level reaches the target value);

11. Intra-procedural bleeding around sheath, or suspected intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula;

12. Systemic hypertension (BP greater than 180/110 mmHg) or hypotension (BP less than 90/60 mmHg) prior to randomization;

13. Length of the tissue tract, the distance between the anterior arterial wall and skin, is estimated to be less than 2.5 cm;

14. If the physician deems that a different method should be used to achieve hemostasis of the arterial site or that the subject should not attempt ambulation according to the protocol requirements.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Hospital	Fairhope	Alabama	United States	36532
2	Christiana Care	Newark	Delaware	United States	19718
3	Holmes Regional Medical Center	Melbourne	Florida	United States	32901
4	St. John's Prairie Heart	Springfield	Illinois	United States	62769
5	St. Vincent's Heart Center of Indiana	Indianapolis	Indiana	United States	46290
6	King's Daughters Medical Center	Ashland	Kentucky	United States	41101
7	Terrebonne General Medical Center	Houma	Louisiana	United States	70360
8	Lafayette General Medical Center	Lafayette	Louisiana	United States	70503
9	Washington Adventist Hospital	Takoma Park	Maryland	United States	20912
10	Tufts University	Boston	Massachusetts	United States	02111
11	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
12	Cooper Health System	Camden	New Jersey	United States	08012
13	Winthrop University Hospital	Mineola	New York	United States	11501
14	New York-Presbyterian Hospital	New York	New York	United States	10065
15	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
16	Oklahoma Heart Institute	Tulsa	Oklahoma	United States	74104
17	Heart Hospital of Austin	Austin	Texas	United States	78756
18	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
19	Virginia Commonwealth University Medical Center	Richmond	Virginia	United States	23298
20	CAMC Health Education and Research Institute, Inc.	Charleston	West Virginia	United States	25304
21	St. Vincent's Hospital Melbourne	Melbourne	Victoria	Australia	3065

Sponsors and Collaborators

• Cardiva Medical, Inc.

Investigators

• Principal Investigator: James B. Hermiller, Jr., MD, FACC, The St. Vincent Heart Center of Indiana, St. Vincent Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 21, 2011

More Information

Publications

• Castañeda F, Swischuk JL, Smouse HB, Brady T. Gelatin sponge closure device versus manual compression after peripheral arterial catheterization procedures. J Vasc Interv Radiol. 2003 Dec;14(12):1517-23.
• Gerckens U, Cattelaens N, Lampe EG, Grube E. Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device. Am J Cardiol. 1999 Jun 15;83(12):1658-63.
• Hoffer EK, Bloch RD. Percutaneous arterial closure devices. J Vasc Interv Radiol. 2003 Jul;14(7):865-85. Review.
• Kinnaird TD, Stabile E, Mintz GS, Lee CW, Canos DA, Gevorkian N, Pinnow EE, Kent KM, Pichard AD, Satler LF, Weissman NJ, Lindsay J, Fuchs S. Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions. Am J Cardiol. 2003 Oct 15;92(8):930-5.
• Kussmaul WG 3rd, Buchbinder M, Whitlow PL, Aker UT, Heuser RR, King SB, Kent KM, Leon MB, Kolansky DM, Sandza JG Jr. Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device. J Am Coll Cardiol. 1995 Jun;25(7):1685-92.
• Lehmann KG, Heath-Lange SJ, Ferris ST. Randomized comparison of hemostasis techniques after invasive cardiovascular procedures. Am Heart J. 1999 Dec;138(6 Pt 1):1118-25.
• Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med. 1998 Apr 30;17(8):873-90. Erratum in: Stat Med 1999 May 30;18(10):1293.
• Simon A, Bumgarner B, Clark K, Israel S. Manual versus mechanical compression for femoral artery hemostasis after cardiac catheterization. Am J Crit Care. 1998 Jul;7(4):308-13.

• Responsible Party: Cardiva Medical, Inc.
• ClinicalTrials.gov Identifier: NCT01297322
• Other Study ID Numbers: PTL 0243
• First Posted: Feb 16, 2011
• Last Update Posted: Jan 22, 2020
• Last Verified: Jan 1, 2020

• Keywords provided by Cardiva Medical, Inc.: vascular closure system; manual compression; femoral arteriotomy; percutaneous endovascular procedures
• Additional relevant MeSH terms: Surgical Wound

Study Results

Participant Flow

Arm/Group Title	Manual Compression	VASCADE™ Vascular Closure System
Arm/Group Description	Manual compression: Standard of Care	Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
Period Title: Overall Study
STARTED	142	278
COMPLETED	141	274
NOT COMPLETED	1	4

Baseline Characteristics

Arm/Group Title	Manual Compression	VASCADE™ Vascular Closure System	Total
Arm/Group Description	Manual compression: Standard of Care	Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System	Total of all reporting groups
Overall Participants	142	275	417
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.5 (10.4)	61.8 (11.2)	62 (10.8)
Sex: Female, Male (Count of Participants)
Female	41 28.9%	79 28.7%	120 28.8%
Male	101 71.1%	196 71.3%	297 71.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 2.8%	4 1.5%	8 1.9%
Asian	0 0%	1 0.4%	1 0.2%
Native Hawaiian or Other Pacific Islander	2 1.4%	2 0.7%	4 1%
Black or African American	6 4.2%	18 6.5%	24 5.8%
White	130 91.5%	249 90.5%	379 90.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 0.4%	1 0.2%

Outcome Measures

1. Primary Outcome

Title	Time to Hemostasis (TTH)
Description	Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.
Time Frame	Up to 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Compression	VASCADE™ Vascular Closure System
Arm/Group Description	Manual compression: Standard of Care	Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
Measure Participants	142	275
Mean (Standard Deviation) [minutes]	21.4 (12.4)	4.8 (5.4)

2. Primary Outcome

Title	Rate of Combined Access Site-related Major Complications
Description	Primary safety endpoint Access site-related bleeding requiring transfusion; Vascular injury requiring repair (via surgery, ultrasound guided compression, transcatheter embolization or stent graft); New ipsilateral lower extremity ischemia causing a threat to the viability of the limb and requiring surgical or additional percutaneous intervention. This compromised blood flow is documented by subject symptoms, physical exam and/or a decreased or absent blood flow on lower extremity angiogram.; Access site-related infection requiring intravenous antibiotics and/or extended hospitalization; New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair; Permanent access site-related nerve injury. (> 30 days)
Time Frame	30 days +/- 7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Compression	VASCADE™ Vascular Closure System
Arm/Group Description	Manual compression: Standard of Care	Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
Measure Participants	142	275
Number [participants]	0 0%	0 0%

3. Secondary Outcome

Title	Time to Ambulation (TTA)
Description	Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding
Time Frame	Up to 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Compression	VASCADE™ Vascular Closure System
Arm/Group Description	Manual compression: Standard of Care	Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
Measure Participants	142	275
Mean (Standard Deviation) [hours]	5.8 (3.1)	3.8 (5.1)

4. Secondary Outcome

Title	Time to Discharge Eligibility (TTDE)
Description	Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is medically able to be discharged based solely on the assessment of the access site, as determined by the medical team
Time Frame	Up to 2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Compression	VASCADE™ Vascular Closure System
Arm/Group Description	Manual compression: Standard of Care	Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
Measure Participants	142	274
Mean (Standard Deviation) [hours]	6.5 (3.3)	4.8 (6.4)

5. Secondary Outcome

Title	Time to Hospital Discharge (TTHD)
Description	Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is actually discharged from the hospital
Time Frame	Up to 2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Compression	VASCADE™ Vascular Closure System
Arm/Group Description	Manual compression: Standard of Care	Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
Measure Participants	142	275
Mean (Standard Deviation) [hours]	13.7 (9.8)	18.3 (34.5)

6. Secondary Outcome

Title	Device Success
Description	Secondary effectiveness endpoint - ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with VASCADE alone or with adjunctive compression
Time Frame	Up to 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VASCADE™ Vascular Closure System
Arm/Group Description	Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
Measure Participants	275
Number [participants]	263 185.2%

7. Secondary Outcome

Title	Procedure Success
Description	Secondary effectiveness endpoint - attainment of final hemostasis using any method and freedom from major vascular complications through 30 days
Time Frame	30 days +/- 7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Compression	VASCADE™ Vascular Closure System
Arm/Group Description	Manual compression: Standard of Care	Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
Measure Participants	142	275
Number [participants]	142 100%	275 100%

8. Secondary Outcome

Title	Rate of Combined Minor Access Site Complications
Description	Secondary safety endpoint Access site-related bleeding requiring greater than 30 minutes to achieve hemostasis; Access site-related hematoma > 6 cm; Late access site-related bleeding (following hospital discharge); Ipsilateral lower extremity arterial emboli; Ipsilateral deep vein thrombosis; Access site-related vessel laceration; Access site wound dehiscence; Localized access site infection treated with intramuscular or oral antibiotics; Arteriovenous fistula not requiring treatment; Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection; Pseudoaneurysm not requiring treatment; New onset access site-related neuropathy in the ipsilateral lower extremity not requiring surgical repair; Ipsilateral pedal pulse diminished by two grades or transiently lost.
Time Frame	30 days +/- 7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Manual Compression	VASCADE™ Vascular Closure System
Arm/Group Description	Manual compression: Standard of Care	Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
Measure Participants	142	275
Number [participants]	10 7%	3 1.1%

Adverse Events

Time Frame	30 days
Arm/Group Title	Manual Compression		VASCADE™ Vascular Closure System
Arm/Group Description	Manual compression: Standard of Care		Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
All Cause Mortality
	Manual Compression		VASCADE™ Vascular Closure System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Manual Compression		VASCADE™ Vascular Closure System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/142 (0%)		0/275 (0%)
Other (Not Including Serious) Adverse Events
	Manual Compression		VASCADE™ Vascular Closure System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/142 (19.7%)		56/275 (20.4%)
Blood and lymphatic system disorders
Anemia	0/142 (0%)	0	1/275 (0.4%)	1
Access site re-bleeding after initial hemostasis confirmed for 5 minutes	4/142 (2.8%)	4	7/275 (2.5%)	7
Ecchymosis - access site	0/142 (0%)	0	1/275 (0.4%)	1
Ecchymosis - nonaccess site	0/142 (0%)	0	1/275 (0.4%)	1
Hematoma - access site	2/142 (1.4%)	2	6/275 (2.2%)	6
Hypervolemia	0/142 (0%)	0	2/275 (0.7%)	2
Cardiac disorders
Severe Hypotension Requiring Treatment	0/142 (0%)	0	3/275 (1.1%)	3
Angina	1/142 (0.7%)	1	3/275 (1.1%)	3
Atrial fibrillation	0/142 (0%)	0	4/275 (1.5%)	4
Cardiac disorders/symptoms	0/142 (0%)	0	3/275 (1.1%)	3
Hypertension	1/142 (0.7%)	1	1/275 (0.4%)	1
Hypotension	1/142 (0.7%)	1	3/275 (1.1%)	3
Ventricular arrhythmia	0/142 (0%)	0	1/275 (0.4%)	1
Ear and labyrinth disorders
ENT disorders/symptoms	0/142 (0%)	0	1/275 (0.4%)	1
Gastrointestinal disorders
GI disorders/symptoms	4/142 (2.8%)	4	5/275 (1.8%)	5
General disorders
Discomfort - nonaccess site	1/142 (0.7%)	1	0/275 (0%)	0
Dizziness	0/142 (0%)	0	1/275 (0.4%)	1
Fall	0/142 (0%)	0	1/275 (0.4%)	1
General disorders/symptoms	2/142 (1.4%)	2	4/275 (1.5%)	4
Headache	4/142 (2.8%)	4	1/275 (0.4%)	1
Pain - access site	3/142 (2.1%)	3	2/275 (0.7%)	2
Pain - nonaccess site	2/142 (1.4%)	2	6/275 (2.2%)	6
Swelling - nonaccess site	0/142 (0%)	0	1/275 (0.4%)	1
Infections and infestations
Infection - access site	0/142 (0%)	0	1/275 (0.4%)	1
Injury, poisoning and procedural complications
Retroperitoneal bleeding (hematoma/hemorrhage)	0/142 (0%)	0	1/275 (0.4%)	1
Musculoskeletal and connective tissue disorders
Ortho disorders/symptoms	1/142 (0.7%)	1	0/275 (0%)	0
Nervous system disorders
Neuro - other	1/142 (0.7%)	1	2/275 (0.7%)	2
Neurological deficit - TIA	0/142 (0%)	0	1/275 (0.4%)	1
Vasovagal episode	2/142 (1.4%)	2	1/275 (0.4%)	1
Psychiatric disorders
Altered mental status	0/142 (0%)	0	4/275 (1.5%)	4
Renal and urinary disorders
Renal Insufficiency	1/142 (0.7%)	1	0/275 (0%)	0
GU disorders/symptoms	0/142 (0%)	0	2/275 (0.7%)	2
Hematuria	0/142 (0%)	0	1/275 (0.4%)	1
Renal failure/insufficiency	0/142 (0%)	0	1/275 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
General disorder/respiratory	1/142 (0.7%)	1	0/275 (0%)	0
Respiratory disorders/symptoms	0/142 (0%)	0	4/275 (1.5%)	4
Skin and subcutaneous tissue disorders
Dermatologic disorders / symptoms	1/142 (0.7%)	1	2/275 (0.7%)	2
Erythema - access site	0/142 (0%)	0	1/275 (0.4%)	1
Rash	1/142 (0.7%)	1	3/275 (1.1%)	3
Surgical and medical procedures
Access site-related tissue tract oozing - prolonged	0/142 (0%)	0	1/275 (0.4%)	1
Discomfort - access site	0/142 (0%)	0	6/275 (2.2%)	6
Vascular disorders
Arterial Thrombosis - peripheral/ non-access site-related	0/142 (0%)	0	1/275 (0.4%)	1
Embolization - peripheral non-access site-related	0/142 (0%)	0	1/275 (0.4%)	1
Vascular repair - non-device related	0/142 (0%)	0	1/275 (0.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.