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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound
• Intervention / Treatment: Other: Manual compression; Device: Cardiva VASCADE™ Vascular Closure System

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 Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3065
      • St. Vincent's Hospital Melbourne
• United States
  • Alabama
    • Fairhope, Alabama, United States, 36532
      • Thomas Hospital
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care
  • Florida
    • Melbourne, Florida, United States, 32901
      • Holmes Regional Medical Center
  • Illinois
    • Springfield, Illinois, United States, 62769
      • St. John's Prairie Heart
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent's Heart Center of Indiana
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • King's Daughters Medical Center
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Terrebonne General Medical Center
    • Lafayette, Louisiana, United States, 70503
      • Lafayette General Medical Center
  • Maryland
    • Takoma Park, Maryland, United States, 20912
      • Washington Adventist Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • New Jersey
    • Camden, New Jersey, United States, 08012
      • Cooper Health System
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • New York, New York, United States, 10065
      • New York-Presbyterian Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
  • Texas
    • Austin, Texas, United States, 78756
      • Heart Hospital of Austin
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University Medical Center
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Health Education and Research Institute, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Ambulation (TTA)	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	Up to 1 day
Time to Discharge Eligibility (TTDE)	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	Up to 2 days
Time to Hospital Discharge (TTHD)	Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is actually discharged from the hospital	Up to 2 days
Device Success	Secondary effectiveness endpoint - ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with VASCADE alone or with adjunctive compression	Up to 1 day
Procedure Success	Secondary effectiveness endpoint - attainment of final hemostasis using any method and freedom from major vascular complications through 30 days	30 days +/- 7 days
Rate of Combined Minor Access Site Complications	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.	30 days +/- 7 days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 15, 2011
• First Posted (ESTIMATE): February 16, 2011

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: manual compression; vascular closure system; femoral arteriotomy; percutaneous endovascular procedures
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: PTL 0243