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

Surgical Wound Clinical Trial

— RESPECT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297322
• Other study ID #: PTL 0243
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: July 2012

Study information

• Verified date: January 2020
• Source: Cardiva Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Wound

Intervention

Other:
• Manual compression
Standard of Care

Device:
• Cardiva VASCADE™ Vascular Closure System
Investigational Hemostatic Vascular Closure System

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital Melbourne	Melbourne	Victoria
United States	King's Daughters Medical Center	Ashland	Kentucky
United States	Heart Hospital of Austin	Austin	Texas
United States	Tufts University	Boston	Massachusetts
United States	Cooper Health System	Camden	New Jersey
United States	CAMC Health Education and Research Institute, Inc.	Charleston	West Virginia
United States	Thomas Hospital	Fairhope	Alabama
United States	Terrebonne General Medical Center	Houma	Louisiana
United States	St. Vincent's Heart Center of Indiana	Indianapolis	Indiana
United States	Lafayette General Medical Center	Lafayette	Louisiana
United States	Holmes Regional Medical Center	Melbourne	Florida
United States	Winthrop University Hospital	Mineola	New York
United States	New York-Presbyterian Hospital	New York	New York
United States	Christiana Care	Newark	Delaware
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	St. John's Prairie Heart	Springfield	Illinois
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Oklahoma Heart Institute	Tulsa	Oklahoma
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cardiva Medical, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (8)

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. — View Citation

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. — View Citation

Hoffer EK, Bloch RD. Percutaneous arterial closure devices. J Vasc Interv Radiol. 2003 Jul;14(7):865-85. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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