RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)
RESPECT
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
1 other identifier
interventional
420
2 countries
21
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Shorter than P25 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 16, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
October 3, 2014
CompletedJanuary 22, 2020
January 1, 2020
9 months
February 10, 2011
September 30, 2014
January 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to Hemostasis (TTH)
Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.
Up to 1 hour
Rate of Combined Access Site-related Major Complications
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)
30 days +/- 7 days
Secondary Outcomes (6)
Time to Ambulation (TTA)
Up to 1 day
Time to Discharge Eligibility (TTDE)
Up to 2 days
Time to Hospital Discharge (TTHD)
Up to 2 days
Device Success
Up to 1 day
Procedure Success
30 days +/- 7 days
- +1 more secondary outcomes
Study Arms (2)
Manual compression
ACTIVE COMPARATORUsing manual compression to reach hemostasis
VASCADE™ Vascular Closure System
EXPERIMENTALThe 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.
Interventions
Investigational Hemostatic Vascular Closure System
Eligibility Criteria
You may qualify if:
- Patients undergoing an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 6 or 7 Fr introducer sheath
You may not qualify if:
- Advanced refusal of blood transfusion, if necessary;
- Active systemic or a cutaneous infection or inflammation;
- Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
- 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);
- Severe co-existing morbidities having a life expectancy of less than 30 days;
- Currently involved in any other investigational clinical trial;
- Ipsilateral femoral arteriotomy within the previous 30 days;
- Planned endovascular procedure within the next 30 days;
- Previous ipsilateral femoral artery closure using a permanent implant-based closure device;
- Previous vascular grafts or surgery at the target vessel access site;
- History of symptomatic peripheral arterial disease, revascularization or deep vein thrombosis in the ipsilateral limb;
- Unilateral or bilateral lower extremity amputation(s);
- Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
- Renal insufficiency (serum creatinine of \> 2.5 mg/dl);
- Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Thomas Hospital
Fairhope, Alabama, 36532, United States
Christiana Care
Newark, Delaware, 19718, United States
Holmes Regional Medical Center
Melbourne, Florida, 32901, United States
St. John's Prairie Heart
Springfield, Illinois, 62769, United States
St. Vincent's Heart Center of Indiana
Indianapolis, Indiana, 46290, United States
King's Daughters Medical Center
Ashland, Kentucky, 41101, United States
Terrebonne General Medical Center
Houma, Louisiana, 70360, United States
Lafayette General Medical Center
Lafayette, Louisiana, 70503, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
Tufts University
Boston, Massachusetts, 02111, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Cooper Health System
Camden, New Jersey, 08012, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
New York-Presbyterian Hospital
New York, New York, 10065, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104, United States
Heart Hospital of Austin
Austin, Texas, 78756, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298, United States
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia, 25304, United States
St. Vincent's Hospital Melbourne
Melbourne, Victoria, 3065, Australia
Related Publications (8)
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.
PMID: 10577443BACKGROUNDSimon 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.
PMID: 9656045BACKGROUNDKussmaul 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.
PMID: 7759724BACKGROUNDCastaneda 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.
PMID: 14654485BACKGROUNDHoffer 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.
PMID: 12847195BACKGROUNDGerckens 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.
PMID: 10392872BACKGROUNDKinnaird 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.
PMID: 14556868BACKGROUNDNewcombe 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.
PMID: 9595617BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael A. Daniel, Consulting VP Regulatory Affairs
- Organization
- Daniel & Daniel Consulting, LLC
Study Officials
- PRINCIPAL INVESTIGATOR
James B. Hermiller, Jr., MD, FACC
The St. Vincent Heart Center of Indiana, St. Vincent Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 16, 2011
Study Start
September 1, 2011
Primary Completion
June 1, 2012
Study Completion
July 1, 2012
Last Updated
January 22, 2020
Results First Posted
October 3, 2014
Record last verified: 2020-01