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

NCT01669382 | Completed Phase 3 DMC

• 1 other identifier: Med2UKEr1/2012
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Acute Coronary Syndromes; Stable Angina Pectoris

Keywords

AngioSeal, ExoSeal, PCI, puncture site

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm within 24 hours after insertion of the device.

  24 hours

Other Outcomes (1)

• lab values

  24 hours

Study Arms (2)

Exo Seal system

ACTIVE COMPARATOR

Percutaneous coronary intervention

Device: percutaneous coronary intervention

AngioSeal system

ACTIVE COMPARATOR

percutaneous coronary intervention

Device: percutaneous coronary intervention

Interventions

percutaneous coronary intervention DEVICE

after the intervention patients are randomized to either Angio Seal or Exo Seal

Also known as: Exo Seal for closure of arterial puncture site

AngioSeal system; Exo Seal system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients who receive coronary angiography/intervention with an 6 F sheath

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Erlangen: lead

Study Sites (3)

Klinikum Coburg

Coburg, 96450, Germany

Location

Universitätsklinikum Erlangen; Medizinische Klinik 2

Erlangen, 91054, Germany

Location

Universitätsklinikum Gießen, Klinik für Kardiologie

Giessen, 35392, Germany

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Angina, Stable

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Harald Rittger, MD

  Universitätsklinikum Erlangen, Medizinische Klinik 2, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.-Doz. Dr. Harald Rittger

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 21, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

DE (3)