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Surgical WoundRESPECTNCT01297322

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

A study testing Manual compression and Cardiva VASCADE™ Vascular Closure System in people with Surgical Wound, run by Cardiva Medical, Inc. at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Surgical Wound
What is being tested?
Manual compression and Cardiva VASCADE™ Vascular Closure System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
21 sitesin 2 countries
Study dates
Sep 2011to Jul 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United States20 sites

  • King's Daughters Medical Center

    Ashland, Kentucky, 41101

  • Heart Hospital of Austin

    Austin, Texas, 78756

  • Tufts University

    Boston, Massachusetts, 02111

  • Cooper Health System

    Camden, New Jersey, 08012

  • CAMC Health Education and Research Institute, Inc.

    Charleston, West Virginia, 25304

  • Thomas Hospital

    Fairhope, Alabama, 36532

  • Terrebonne General Medical Center

    Houma, Louisiana, 70360

  • St. Vincent's Heart Center of Indiana

    Indianapolis, Indiana, 46290

  • Lafayette General Medical Center

    Lafayette, Louisiana, 70503

  • Holmes Regional Medical Center

    Melbourne, Florida, 32901

  • Winthrop University Hospital

    Mineola, New York, 11501

  • New York-Presbyterian Hospital

    New York, New York, 10065

  • Christiana Care

    Newark, Delaware, 19718

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • St. John's Prairie Heart

    Springfield, Illinois, 62769

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

Australia1 site

  • St. Vincent's Hospital Melbourne

    Melbourne, Victoria, 3065

Other trials in Australia

About this study

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

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.

Read the 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
Being tested
Manual compression, Cardiva VASCADE™ Vascular Closure System
Keywords
vascular closure system, manual compression, femoral arteriotomy, percutaneous endovascular procedures
Medical subject headings
Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manual compressionOther

    Standard of Care

  • Cardiva VASCADE™ Vascular Closure SystemDevice

    Investigational Hemostatic Vascular Closure System

Study groups in NCT01297322
Study groupRoleWhat they receive
Manual compressionActive comparatorUsing manual compression to reach hemostasis
Receives: Other: Manual compression
VASCADE™ Vascular Closure SystemExperimentalThe 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.
Receives: Device: Cardiva VASCADE™ Vascular Closure System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Hemostasis (TTH)

    Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.

    Measured: Up to 1 hour

  2. 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)

    Measured: 30 days +/- 7 days

Secondary outcomes (6)

  1. 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

    Measured: Up to 1 day

  2. 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

    Measured: Up to 2 days

  3. 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

    Measured: Up to 2 days

  4. Device Success

    Secondary effectiveness endpoint - ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with VASCADE alone or with adjunctive compression

    Measured: Up to 1 day

  5. Procedure Success

    Secondary effectiveness endpoint - attainment of final hemostasis using any method and freedom from major vascular complications through 30 days

    Measured: 30 days +/- 7 days

  6. 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.

    Measured: 30 days +/- 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionJun 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01297322
Sponsor's protocol ID
PTL 0243
Acronym
RESPECT
Status last verified
Jan 2020
First submitted
10 Feb 2011
Last updated
22 Jan 2020
Data monitoring committee
Yes

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.

    PubMed 10577443

  • 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.

    PubMed 9656045

  • 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.

    PubMed 7759724

  • 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.

    PubMed 14654485

  • 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.

    PubMed 12847195

  • 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.

    PubMed 10392872

  • 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.

    PubMed 14556868

  • 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.

    PubMed 9595617

Questions about this trial

What is this clinical trial studying?

A study testing Manual compression and Cardiva VASCADE™ Vascular Closure System in people with Surgical Wound, run by Cardiva Medical, Inc. at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Hemostasis (TTH) (time frame: Up to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01297322, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.

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