NCT01121510WithdrawnPhase 1
The QuickClose Design 9 System Study
CardioDex2 sites in 1 country50 target enrollmentStarted: May 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- rate of complications
Study Overview
Brief 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.
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Thrombocytopenia (Plt count ≤ 100,000)
- •Anemia (Hgb ≤ 10mg/dl and/or Hct ≤ 30mg/dl)
- •Von Willebrand"s disease
- •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
Outcomes
Primary Outcomes
rate of complications
Time Frame: 30 days
Establishing a rate of major complications
Secondary Outcomes
- time to hemostasis(procedure day)
Investigators
Study Sites (2)
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