Acute Coronary Syndromes Clinical Trial
Official title:
ACCESS: A Randomized, Multicenter, Single-Blinded Trial to Compare the Extrafemoral Closure Device Exo-Seal® and the Collagen-based Intravascular Device Angio-SealTM for Arterial Puncture Site Closure.
Verified date | February 2015 |
Source | University Hospital Erlangen |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
Background:
Vascular closure devices (VCD) were developed to reduce access site bleedings, to improve
patients´ comfort, and to accelerate ambulation after percutaneous coronary interventions
(PCI). Despite higher complications rates in earlier studies, current data suggest similar
complication rates or better outcomes after the use of VCD as compared to manual
compression. ExoSeal (Cordis, Warren, NJ, USA) is a new, extravascular polyglycol acid (PGA)
plug which occludes the puncture channel. Whether the use of this extravascular closure
device is as effective as the more widely used plug/anchor mediated devices, has not been
evaluated so far.
We performed a randomized, multicentre, single-blinded trial to compare the efficacy of the
extravascular closure device ExoSeal in comparison to the collagen-based plug/anchor
mediated AngioSeal system.
Methods:
304 patients receiving diagnostic angiography and/or PCI will be included in three centers.
Exclusion criteria are contraindications for any VCD including 1. severe calcification of
the access vessel, 2. severe peripheral artery disease, 3. puncture in the origin of the
profound femoral artery, 3. non-femoral sheath insertion, 4. marked tortuosity of the
femoral or iliac artery, 5. marked obesity or cachexia (BMI >40 or <20) and 6. patients on
continuous medication with oral anticoagulants.
After the procedure, angiography of the accessed femoral artery is performed to rule out
major risk factors for retroperitoneal hemorrhage, relevant peripheral stenoses of the
common or the superficial femoral artery, or a location of the puncture site in the
bifurcation of the profundal femoral artery.
We hypothesise, that the use of an extravascular closure device is not inferior to an
anchor/plug mediated device regarding the occurrence of the following complications:
bleeding, need for vascular surgery and device failure (primary endpoints). Secondary
endpoints are the occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm
within 24 hours after insertion of the device. Power was 80%, alpha 0.05. Bleeding will be
defined according to the TIMI criteria. The study is actively enrolling patients, last
inclusion will take place in September 2012.
Results and Conclusions:
Outcome data including the primary endpoint (bleeding, need for vascular surgery and device
failure) will be presented for the first time.
Status | Completed |
Enrollment | 304 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - all patients who receive coronary angiography/intervention with an 6 F sheath Exclusion Criteria: - severe calcification of the access vessel, - severe peripheral artery disease, - puncture in the origin of the profound femoral artery, - non-femoral sheath insertion, - marked tortuosity of the femoral or iliac artery, - marked obesity or cachexia (BMI >40 or <20) - patients on continuous medication with oral anticoagulants. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Coburg | Coburg | |
Germany | Universitätsklinikum Erlangen; Medizinische Klinik 2 | Erlangen | |
Germany | Universitätsklinikum Gießen, Klinik für Kardiologie | Gießen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Erlangen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | lab values | red blood count after 24 hours | 24 hours | Yes |
Primary | bleeding, need for vascular surgery and device failure | bleeding, need for vascular surgery and device failure will be measured as primary endpoints within the first 24 hours. | 24 hours | Yes |
Secondary | occurrence of false aneurysms, severe pain (Borg = 5), and hematoma = 5 cm within 24 hours after insertion of the device. | Secondary endpoints are the occurrence of false aneurysms, severe pain (Borg = 5), and hematoma = 5 cm within 24 hours after insertion of the device. | 24 hours | Yes |
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