Evaluation of the CloSys Closure System as an Adjunct to Standard Compression
This trial is active, not recruiting.
|Treatments||closys hemostatic device (hd), standard compression|
|Collaborator||Eminence Clinical Research, Inc.|
|Start date||August 2009|
|End date||December 2015|
|Trial size||130 participants|
|Trial identifier||NCT00963690, CL-0100-01|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Primary purpose||supportive care|
Time to hemostasis
time frame: 1 Hour
Time to ambulation
time frame: 6 Hours
time frame: Within 30 days after procedure
Male or female participants at least 18 years old.
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; 126.96.36.199 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: 188.8.131.52 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.
|Official title||CloSys Hemostatic Device U.S. Multi-Center Clinical Investigation|
|Principal investigator||George Adams, MD|
|Description||To analyze the time to hemostasis (time to stop bleeding), time to ambulation (time to walk) and adverse events.|
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