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

January 30, 2017 updated by: CloSys Corporation

CloSys Hemostatic Device U.S. Multi-Center Clinical Investigation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
        • Cardiovascular Institute of the South
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Rex Healthcare - Rex Heart and Vascular Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to hemostasis
Time Frame: 1 Hour
1 Hour
Time to ambulation
Time Frame: 6 Hours
6 Hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Within 30 days after procedure
Within 30 days after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CloSys Corporation

Collaborators

Eminence Clinical Research, Inc.

Investigators

  • Principal Investigator: George Adams, MD, Rex Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2009

Primary Completion (Actual)

April 30, 2013

Study Completion (Actual)

May 30, 2013

Study Registration Dates

First Submitted

August 12, 2009

First Submitted That Met QC Criteria

August 20, 2009

First Posted (Estimate)

August 21, 2009

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-0100-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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