Evaluation of the CloSys Closure System as an Adjunct to Standard Compression

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Eminence Clinical Research, Inc.
Information provided by (Responsible Party):
CloSys Corporation
ClinicalTrials.gov Identifier:
NCT00963690
First received: August 12, 2009
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the safety and efficacy of the CloSys Hemostatic Device designed to stop bleeding after an interventional procedure.


Condition Intervention
Vascular Closure
Device: CloSys Hemostatic Device (HD)
Procedure: Standard compression

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: CloSys Hemostatic Device U.S. Multi-Center Clinical Investigation

Further study details as provided by CloSys Corporation:

Primary Outcome Measures:
  • Time to hemostasis [ Time Frame: 1 Hour ] [ Designated as safety issue: No ]
  • Time to ambulation [ Time Frame: 6 Hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Within 30 days after procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: August 2009
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CloSys HD with standard compression
CloSys Arm
Device: CloSys Hemostatic Device (HD)
Deploy CloSys HD to achieve hemostasis
Procedure: Standard compression
Use standard compression to achieve hemostasis
Active Comparator: Standard compression alone
Manual compression arm
Procedure: Standard compression
Use standard compression to achieve hemostasis

Detailed Description:

To analyze the time to hemostasis (time to stop bleeding), time to ambulation (time to walk) and adverse events.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria

All answers must be YES to be eligible for the study:

  1. Subject is ≥ 18 years of age;
  2. Subject is willing and able to provide informed consent;
  3. Subject is able to ambulate pre-procedure without difficulty;
  4. Subject is able to remain supine for an extended period of time;
  5. Subject is willing and able to comply with the requirements of the study protocol, including all follow-up visit evaluations;

General Exclusion Criteria

All answers must be NO to be eligible for the study:

  1. Subject has a systolic blood pressure (SBP) ≥ 160 mmHg despite medical therapy;
  2. Subject has a diastolic blood pressure (DBP) ≥ 100 mmHg despite medical therapy;
  3. Subject has received thrombolytic therapy, such as streptokinase, urokinase, retavase, tenecteplase, or tPA, within 24 hours of the scheduled procedure;
  4. Subject is lactating;
  5. Subject has a life expectancy of less than one (1) year;
  6. The percutaneous intervention was an emergent procedure;
  7. Subject has a known coagulopathy disorder, including, but not limited to, hemophilia, sickle cell disease, or von Willebrand disease;
  8. Subject has a known diagnosis of an auto-immune disease;
  9. Subject has a known or suspected diagnosis of vasculitis;
  10. Subject currently has an infection of any kind;
  11. Subject does not have either a posterior Tibialis (PT) or dorsalis pedis (DP) pulse by doppler in ipsilateral extremity;
  12. Subject has critical limb ischemia and/or severe peripheral vascular disease as identified by rest pain and/or gangrene;
  13. Rutherford category five (5) or six (6);
  14. Subject is currently or within the last thirty (30) days participating in another investigational drug or device study;
  15. Subject is unavailable for follow-up;
  16. Subject has known allergy or previous intolerance to Protamine Sulfate;
  17. Subject has known allergy to shellfish;
  18. Subject has had a previous closure device in the ipsilateral side within the last ninety (90) days;
  19. Prior intervention or surgical procedure to the access site within the last six (6) months;
  20. Subject has a planned intervention or surgical procedure prior to completion of the thirty (30) day follow-up visit;
  21. Subject has received a low molecular weight (LMWH) heparin, such as, Enoxaparin sodium (Lovenox, Xaparin and Clexane) within the past twelve (12) hours;
  22. Body mass index (BMI) > 45 or < 20;
  23. The investigator determines the subject is otherwise not an appropriate subject for the study; 5.3.2.1 Laboratory Values Exclusion Criteria

All answers must be NO to be eligible for the study:

Within seven (7) days prior to interventional procedure or according to standard of care for percutaneous interventional procedures requiring contrast and angiography:

  1. Subject is known to be, or suspected to be, pregnant (verified with a urine/blood pregnancy test);
  2. Subject's pre-procedural platelet count < 100,000 103/ul;
  3. Subject's hematocrit < 28%;
  4. Subject's hemoglobin < 10 g/dL;
  5. Subject's serum creatinine ≥ 2.5 mg/dL;
  6. Prothrombin Time (PT) is not within normal limits;
  7. Partial Thromboplastin Time (PTT) is not within normal limits;
  8. For subjects taking warfarin (Coumadin): The subject on warfarin within 30 days has an INR ≥ 1.8 at the time of procedure;

post - Interventional Procedure Inclusion Criteria

All answers must be YES to be eligible for the study:

  1. Subject has undergone a percutaneous interventional procedure utilizing a femoral arterial access;
  2. Heparin is administered for anti-coagulation during the procedure;
  3. Subject has an ACT ≥ 225 seconds and < 350 seconds;
  4. Subject's arterial introducer sheath is 5 Fr, 6 Fr or 7 Fr;
  5. Subject's arterial introducer sheath has an overall length of ≤ 15.0 cm;
  6. Subject's SBP < 160 mmHg;
  7. Subject's DBP < 100mmHg;
  8. Subject's physical, mental, and clinical status is stable and allows for ambulation assessment four (4) hours following removal of introducer sheath; 5.3.4 Post - Interventional Procedure Exclusion Criteria

All answers must be NO to be eligible for the study:

5.3.4.1 General Exclusion Criteria

  1. Subject experienced cardiogenic shock before, during, or immediately after the interventional procedure;
  2. Subject has bleeding around the sheath prior to sheath removal;
  3. Subject has a pseudoaneurysm before sheath removal;
  4. Subject has a palpable hematoma before sheath removal;
  5. Subject has evidence of a retroperitoneal bleed prior to sheath removal;
  6. Subject experienced double wall punctures during vascular access;
  7. Subject experienced multiple arterial punctures (> 1) during vascular access;
  8. Subject has ipsilateral venous sheaths;
  9. Subject had intraprocedural therapeutic thrombolysis;
  10. Subject received bivalirudin(Angiomax®) before, during, or after the intervention;
  11. Subject received Protamine Sulfate IV to reverse heparin received during procedure;
  12. Subject has a suspected bacterial contamination of the access site;
  13. Arterial access was obtained in or near a vascular graft;
  14. Subject's percutaneous intervention was for the treatment of an acute myocardial infarction (MI);

Angiographic Eligibility Criteria Angiographic Inclusion Criteria

All answers must be YES to be eligible for the trial:

  1. Arterial access was obtained above the femoral bifurcation;
  2. Arterial access was obtained below the inguinal ligament; Angiographic Exclusion Criteria

All answers must be NO to be eligible for the trial:

  1. Common femoral artery > 50% narrowing due to calcification or plaque;
  2. Arteriovenous fistula present;
  3. Other complication noted on femoral angiogram.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963690

Locations
United States, Indiana
St. Vincent Medical Group
Indianapolis, Indiana, United States, 46290
United States, Louisiana
Cardiovascular Institute of the South
Lafayette, Louisiana, United States, 70506
United States, North Carolina
Rex Healthcare - Rex Heart and Vascular Research
Raleigh, North Carolina, United States, 27607
Sponsors and Collaborators
CloSys Corporation
Eminence Clinical Research, Inc.
Investigators
Principal Investigator: George Adams, MD Rex Healthcare
  More Information

No publications provided

Responsible Party: CloSys Corporation
ClinicalTrials.gov Identifier: NCT00963690     History of Changes
Other Study ID Numbers: CL-0100-01
Study First Received: August 12, 2009
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014