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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01297322




Registration number
NCT01297322
Ethics application status
Date submitted
10/02/2011
Date registered
16/02/2011
Date last updated
22/01/2020

Titles & IDs
Public title
RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)
Scientific 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
Secondary ID [1] 0 0
PTL 0243
Universal Trial Number (UTN)
Trial acronym
RESPECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical Wound 0 0
Condition category
Condition code
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Manual compression
Treatment: Devices - Cardiva VASCADE™ Vascular Closure System

Active comparator: Manual compression - Using manual compression to reach hemostasis

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.


Other interventions: Manual compression
Standard of Care

Treatment: Devices: Cardiva VASCADE™ Vascular Closure System
Investigational Hemostatic Vascular Closure System
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Hemostasis (TTH)
Timepoint [1] 0 0
Up to 1 hour
Primary outcome [2] 0 0
Rate of Combined Access Site-related Major Complications
Timepoint [2] 0 0
30 days +/- 7 days
Secondary outcome [1] 0 0
Time to Ambulation (TTA)
Timepoint [1] 0 0
Up to 1 day
Secondary outcome [2] 0 0
Time to Discharge Eligibility (TTDE)
Timepoint [2] 0 0
Up to 2 days
Secondary outcome [3] 0 0
Time to Hospital Discharge (TTHD)
Timepoint [3] 0 0
Up to 2 days
Secondary outcome [4] 0 0
Device Success
Timepoint [4] 0 0
Up to 1 day
Secondary outcome [5] 0 0
Procedure Success
Timepoint [5] 0 0
30 days +/- 7 days
Secondary outcome [6] 0 0
Rate of Combined Minor Access Site Complications
Timepoint [6] 0 0
30 days +/- 7 days

Eligibility
Key inclusion criteria
Pre-Operative

* 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2012
Sample size
Target
Accrual to date
Final
420
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
West Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cardiva Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01297322
Trial related presentations / publications
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. doi: 10.1016/s0002-8703(99)70078-5.
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.
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. doi: 10.1016/0735-1097(95)00101-9.
Castaneda 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. doi: 10.1097/01.rvi.0000099530.29957.dd.
Hoffer EK, Bloch RD. Percutaneous arterial closure devices. J Vasc Interv Radiol. 2003 Jul;14(7):865-85. doi: 10.1097/01.rvi.0000071086.76348.8e.
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. doi: 10.1016/s0002-9149(99)00174-5.
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. doi: 10.1016/s0002-9149(03)00972-x.
Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med. 1998 Apr 30;17(8):873-90. doi: 10.1002/(sici)1097-0258(19980430)17:83.0.co;2-i. Erratum In: Stat Med 1999 May 30;18(10):1293.
Public notes

Contacts
Principal investigator
Name 0 0
James B. Hermiller, Jr., MD, FACC
Address 0 0
The St. Vincent Heart Center of Indiana, St. Vincent Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01297322