Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System

Coagulation Clinical Trial

Official title:

The QuickClose Design 9 System Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01121510
• Other study ID #: RD 655-03
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: May 10, 2010
• Last updated: September 28, 2010
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: September 2010
• Source: CardioDex
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The QuickClose Design 9 is a prospective, non randomized study, to evaluate the safety and efficacy of the QuickClose design 9 closure device.

patient undergoing a diagnostic or therapeutic angiogram procedure will be treated with the QuickClose Design 9. Patients will be monitored until 30 days after the procedure.

Description:

the primary safety endpoint is the incidence of major complications related to method for achieving hemostasis at the puncture site. the secondary safety endpoints is the incidence of minor complications related to method for achieving hemostasis at the puncture site. the primary efficacy endpoints are time to hemostasis, time to ambulation and time to discharge. the secondary efficacy endpoints are device and procedure success

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 50
• Est. completion date: May 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• patient/legal representative provides written informed consent

• Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure

• Target vessel has a lumen diameter = 6 mm

• Patient must be willing to comply with follow-up requirements

• Patient has a 5-7F arterial puncture located in the common femoral artery

Exclusion Criteria:

• Arterial puncture in the femoral artery of both legs

• Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks

• Any closure system has been used on the ipsilateral arterial site within the previous 180 days

• Any reentry of the ipsilateral site is planned within the next 6 weeks

• History of surgical repair of blood vessels of the ipsilateral arterial site

• Patient is unable to ambulate at baseline

• Significant bleeding diathesis or platelet dysfunction

1. Thrombocytopenia (Plt count = 100,000)

2. Anemia (Hgb = 10mg/dl and/or Hct = 30mg/dl)

3. Hemophilia

4. Von Willebrand"s disease

5. Thrombophilia (i.e. factor 5 deficiency or other)

• ST-elevation myocardial infarction = 48 hours prior to the cardiac or peripheral catheterization procedure

• Pre-existing severe non-cardiac systemic disease or pre-existing terminal illness

• Pre-existing systemic or cutaneous infection

• Receiving warfarin therapy within the last 14 days.

• INR results > 1.2 on day of procedure for any patient with a history of warfarin therapy

• Thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) = 24 hours prior to the cardiac or peripheral catheterization procedure

• Concurrent participation in another investigational device or drug trial

• Angiomax (bivalirudin) or other thrombin-specific anticoagulants or low molecular weight heparin = 24 hours prior to the cardiac or peripheral catheterization procedure

• Planned arterial access at the same access site = 30 days following the femoral artery closure procedure

• Evidence of a preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to start of femoral artery closure procedure

• Prior femoral vascular surgery or vascular graft in region of access site or contralateral common femoral artery

• Symptomatic leg ischemia in the target vessel limb including severe claudication or weak/absent pulse

• Absent of pedal pulse on ipsilateral side

• Pre-existing autoimmune disease

• BMI > 40 kg/m2

• The targeted femoral artery is tortuous or requires an introducer sheath length > 11 cm

• Fluoroscopically visible calcium, atherosclerotic disease, or stent = 1 cm of the puncture site that would interfere with the placement of the VCD's plug

• Suspected bacterial contamination of access site

• Puncture through a vascular graft

• Double wall puncture

• Antegrade puncture

• Palpable Hematoma

• Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture

• Any Arterial and/or Venous access on the ipsilateral or contralateral groin other than target study access site

• Patient is not cooperative

• Intra-procedural therapeutic thrombolysis is preformed

• Uncontrolled hypertension at time of sheath removal (blood pressure = 170 mmHg systolic and/or = 100mmHg diastolic)

• Peripheral vascular disease on the ipsilateral arterial vessel (= 50% stenosis) or aneurismal disease of this vessel.

• Sheaths has been changed during the procedure

• Heparinized patients with elevated pre-closure ACT level= 300 seconds

• Patient has known allergy to any materials used in the VCD

• Patient is known to require an extended hospitalization (e.g. patient is undergoing CABG surgery)

• Prior or recent use of an intra-aortic balloon pump through the arterial access site

• Cardiogenic shock (hemodynamic instability requiring intravenous medications or mechanical support) experienced during or immediately post-catheterization

• Patient is known or suspected to be pregnant, or is lactating

• Patient has known allergy to contrast medium

• Any angiographic or clinical evidence that the investigator feels would place the patient at increased risk with the use of the VCD

• Required simultaneous ipsilateral or contralateral venous puncture

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coagulation
• Pharmacologic Actions
• Therapeutic Uses

Intervention

Device:
• closure device
the invasive specialist must carefully manage the difficult balance of patient anticoagulation and coagulation for stopping the bleeding at the femoral artery puncture site. the QuickClose design 9 system is designed to benefit the patients and the medical staff by improving the process. the risks to patients associated with this study are considered reasonable in comparison to the anticipated benefits to the subjects, and the scientific knowledge that can be gained from the study.

Locations

Country	Name	City	State
Israel	Heart Institute Sheba medical center	Tel Hashomer

Sponsors (2)

Lead Sponsor	Collaborator
CardioDex	Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of complications	Establishing a rate of major complications	30 days	Yes
Secondary	time to hemostasis	establishing a rate of time to hemostasis	procedure day	No