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Angio-Seal® vs. Exo-Seal® for Closure of Arterial Puncture Sites

This study is currently recruiting participants.
Verified August 2012 by University Hospital Erlangen
Sponsor:
Information provided by (Responsible Party):
Harald Rittger, University Hospital Erlangen
ClinicalTrials.gov Identifier:
NCT01669382
First received: August 9, 2012
Last updated: August 20, 2012
Last verified: August 2012
History of Changes
  Purpose

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 polyglykolacid (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 turtuosity of the femoral or iliac artery, 5. marked obesity or kachexia (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 occurance 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.


Condition Intervention Phase
Acute Coronary Syndromes
Stable Angina Pectoris
 Device: percutaneous coronary intervention
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Angina
U.S. FDA Resources

Further study details as provided by University Hospital Erlangen:

Primary Outcome Measures:
  • bleeding, need for vascular surgery and device failure [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    bleeding, need for vascular surgery and device failure will be measured as primary endpoints within the first 24 hours.


Secondary Outcome Measures:
  • occurance of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm within 24 hours after insertion of the device. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Secondary endpoints are the occurance of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm within 24 hours after insertion of the device.


Other Outcome Measures:
  • lab values [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    red blood count after 24 hours


Estimated Enrollment: 304
Study Start Date: January 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exo Seal system
Percutaneous coronary intervention
 Device: percutaneous coronary intervention
after the intervention patients are randomized to either Angio Seal or Exo Seal
Other Name: Exo Seal for closure of arterial puncture site
Active Comparator: AngioSeal system
percutaneous coronary intervention
 Device: percutaneous coronary intervention
after the intervention patients are randomized to either Angio Seal or Exo Seal
Other Name: Exo Seal for closure of arterial puncture site

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 turtuosity of the femoral or iliac artery,
  • marked obesity or kachexia (BMI >40 or <20)
  • patients on continuous medication with oral anticoagulants.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669382

Locations
Germany
Klinikum Coburg Recruiting
Coburg, Germany, 96450
Contact: Johannes Brachmann, MD     0049-9651-8220 ext 6348     johannes.brachmann@klinikum-coburg.de    
Contact: Barbara Bluem, MD     0049-9561-8220 ext 33210     barbara.bluem@klinikum-coburg.de    
Principal Investigator: Johannes Brachmann, MD            
Universitätsklinikum Erlangen; Medizinische Klinik 2 Recruiting
Erlangen, Germany, 91054
Contact: Harald Rittger, MD     0049-9131-85 ext 45348     harald.rittger@uk-erlangen.de    
Contact: Johannes Ketterle, MD     0049-9131-85 ext 45341     johannes.ketterle@uk-erlangen.de    
Principal Investigator: Harald Rittger, MD            
Universitätsklinikum Gießen, Klinik für Kardiologie Recruiting
Gießen, Germany, 35392
Contact: Holger Nef, MD     0049-641-985 ext 42101     holger.nef@innere.med.uni-giessen.de    
Principal Investigator: Holger Nef, MD            
Sponsors and Collaborators
University Hospital Erlangen
Investigators
Principal Investigator: Harald Rittger, MD Universitätsklinikum Erlangen, Medizinische Klinik 2, Germany
  More Information

No publications provided

Responsible Party: Harald Rittger, Priv.-Doz. Dr. Harald Rittger, University Hospital Erlangen
ClinicalTrials.gov Identifier: NCT01669382     History of Changes
Other Study ID Numbers: Med2UKEr1/2012
Study First Received: August 9, 2012
Last Updated: August 20, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Erlangen:
AngioSeal, ExoSeal, PCI, puncture site

Additional relevant MeSH terms:
Angina Pectoris
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013