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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00963690
Recruitment Status : Terminated (Lack of funding)
First Posted : August 21, 2009
Last Update Posted : January 31, 2017
Eminence Clinical Research, Inc.
Information provided by (Responsible Party):
CloSys Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Sealing the Arteriotomy Device: CloSys Hemostatic Device (HD) Procedure: Standard compression Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: CloSys Hemostatic Device U.S. Multi-Center Clinical Investigation
Actual Study Start Date : August 2009
Actual Primary Completion Date : April 30, 2013
Actual Study Completion Date : May 30, 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Time to hemostasis [ Time Frame: 1 Hour ]
  2. Time to ambulation [ Time Frame: 6 Hours ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Within 30 days after procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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; 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: 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00963690

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.
Principal Investigator: George Adams, MD Rex Healthcare

Responsible Party: CloSys Corporation Identifier: NCT00963690     History of Changes
Other Study ID Numbers: CL-0100-01
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

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