Coronary Angiography Via Femoral Artery Access Clinical Trial
— CLOSE-UP IOfficial title:
Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography: the CLOSE-UP I Randomized Trial
Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?
| Status | Completed |
| Enrollment | 1005 |
| Est. completion date | September 2010 |
| Est. primary completion date | September 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - The patient must be at least 18 years old - Patients undergoing femoral access coronary angiography - Patient must be competent for providing informed, written consent - Only 6F sheath Exclusion Criteria: - Percutaneous coronary intervention - Intra coronary measurements (FFR, IVUS, OCT, NIR) - Groin hematoma before closure - Pseudoaneurysm or AV fistula - Significant stenosis of ilial or femoral artery - Prior peripheral artery surgery - INR > 3,0 - Platelet count < 120 million per millilitre blood - Coagulopathy (bleeding disorder) - Thrombolysis in the last 24h - Planned heparin infusion after the procedure - Pregnancy - Uncontrolled hypertension > 200 mmHg / 110 mmHg - Femoral access device closure in the last 30 days |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Aarhus University Hospital Skejby | Aarhus N |
| Lead Sponsor | Collaborator |
|---|---|
| Aarhus University Hospital Skejby | Vingmed Danmark A/S |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. | 20 minutes, 1 hour and at discharge, pooled | Yes | |
| Secondary | Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. Patient self-measurements. | 14 days | Yes | |
| Secondary | Composite of: major vascular complications necessitating surgical repair, A-V fistulation, pseudoaneurysm needing treatment, major bleeding needing transfusion and infection needing antibiotics . | 14 days | Yes | |
| Secondary | Time to hemostasis, from sheath removal to hemostasis is achieved | 14 days | Yes | |
| Secondary | Time from end of closure procedure to ambulation. 1h bedrest recommended. | 14 days | Yes | |
| Secondary | Device deployment failure | 20 minutes | Yes | |
| Secondary | Time to cessation of continuous minor oozing measured from the end of the closure procedure | 14 days | Yes | |
| Secondary | Need for repeated manual compression after end of the closure procedure | 14 days | Yes | |
| Secondary | Pain and discomfort measured on a numerical pain rating scale (0-10) | 20 min | Yes | |
| Secondary | Vasovagal reaction (clinical signs AND Systolic BP drop of more than 30 mmHg AND/OR pulse drop more than 30 b/min. AND reversible immediately after treatment by atropin, fluids) | 20 minutes | Yes | |
| Secondary | The patient seeking medical assistance for all-cause closure site related symptoms after discharge. | 14 days | Yes | |
| Secondary | Pain and discomfort measured on a numerical pain rating scale (0-10) | 1 hour | Yes | |
| Secondary | Pain and discomfort measured on a numerical pain rating scale (0-10) | Discharge | Yes | |
| Secondary | Pain and discomfort measured on a numerical pain rating scale (0-10) | 14 days | Yes |