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

NCT ID: NCT01297322

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-07-31

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.

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.

Conditions

Surgical Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Manual compression

Using manual compression to reach hemostasis

Group Type: ACTIVE_COMPARATOR

Manual compression

Intervention Type: OTHER

Standard of Care

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.

Group Type: EXPERIMENTAL

Cardiva VASCADE™ Vascular Closure System

Intervention Type: DEVICE

Investigational Hemostatic Vascular Closure System

Interventions

Manual compression

Standard of Care

Intervention Type: OTHER

Cardiva VASCADE™ Vascular Closure System

Investigational Hemostatic Vascular Closure System

Intervention Type: DEVICE

Eligibility Criteria

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

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiva Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James B. Hermiller, Jr., MD, FACC

Role: PRINCIPAL_INVESTIGATOR

The St. Vincent Heart Center of Indiana, St. Vincent Hospital

Locations

Heart Hospital of Austin

Austin, Texas, United States

Thomas Hospital

Fairhope, Alabama, United States

Christiana Care

Newark, Delaware, United States

Holmes Regional Medical Center

Melbourne, Florida, United States

St. John's Prairie Heart

Springfield, Illinois, United States

St. Vincent's Heart Center of Indiana

Indianapolis, Indiana, United States

King's Daughters Medical Center

Ashland, Kentucky, United States

Terrebonne General Medical Center

Houma, Louisiana, United States

Lafayette General Medical Center

Lafayette, Louisiana, United States

Washington Adventist Hospital

Takoma Park, Maryland, United States

Tufts University

Boston, Massachusetts, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Cooper Health System

Camden, New Jersey, United States

Winthrop University Hospital

Mineola, New York, United States

New York-Presbyterian Hospital

New York, New York, United States

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Oklahoma Heart Institute

Tulsa, Oklahoma, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

CAMC Health Education and Research Institute, Inc.

Charleston, West Virginia, United States

St. Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

Countries

United States; Australia

References

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.

Reference Type: BACKGROUND

PMID: 10577443 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9656045 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7759724 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14654485 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12847195 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10392872 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14556868 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9595617 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PTL 0243

Identifier Type: -

Identifier Source: org_study_id