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

NCT ID: NCT00963690

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-05-30

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.

Detailed Description

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

Conditions

Sealing the Arteriotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CloSys HD with standard compression

CloSys Arm

Group Type: EXPERIMENTAL

CloSys Hemostatic Device (HD)

Intervention Type: DEVICE

Deploy CloSys HD to achieve hemostasis

Standard compression

Intervention Type: PROCEDURE

Use standard compression to achieve hemostasis

Standard compression alone

Manual compression arm

Group Type: ACTIVE_COMPARATOR

Standard compression

Intervention Type: PROCEDURE

Use standard compression to achieve hemostasis

Interventions

CloSys Hemostatic Device (HD)

Deploy CloSys HD to achieve hemostasis

Intervention Type: DEVICE

Standard compression

Use standard compression to achieve hemostasis

Intervention Type: PROCEDURE

Eligibility Criteria

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;

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;

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

1. Arterial access was obtained above the femoral bifurcation;

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;

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;

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

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);

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eminence Clinical Research, Inc.

INDUSTRY

Sponsor Role: collaborator

CloSys Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Adams, MD

Role: PRINCIPAL_INVESTIGATOR

Rex Healthcare

Locations

Cardiovascular Institute of the South

Lafayette, Louisiana, United States

Rex Healthcare - Rex Heart and Vascular Research

Raleigh, North Carolina, United States

Countries

United States

Other Identifiers

CL-0100-01

Identifier Type: -

Identifier Source: org_study_id