Clinical Trial: Catheter Thrombectomy in Patients With Massive Pulmonary Embolism
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism
Brief Summary:
Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism
Study Population: Patients >/= 18 years of age with massive pulmonary embolism suitable for mechanical thrombectomy with Aspirex 11F.
Treatment: Aspirex 11F assisted thrombectomy
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The study was terminated early. After having treated seven (7) patients, it was decided in April 2007 that the handling characteristics of the test device should be upgraded before continuing the trial as planned. Therefore, the study was long-term interrupted and finally terminated early. This decision was made by the sponsor in full accordance with the principal investigator. Further studies shall be conducted to show effectiveness and safety of the Aspirex PE catheter thrombectomy device.
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Primary Endpoints:
- Thrombectomy with the Aspirex catheter device is associated with an immediate decrease in mean pulmonary artery pressure (PAP) and pulmonary vascular resistance (PVP).
- The Aspirex thrombectomy catheter does not cause perforation/dissection to treated and untreated cardiovascular structures.
Secondary Endpoints:
- Thrombectomy with the Aspirex catheter device is associated with improved flow in the treated main and lobar pulmonary arteries as assessed by the angiographic Miller index.
- There will be no significant mechanical h
Detailed Summary:
Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism
Principal Investigator: Nils Kucher, MD, Cardiovascular Division, Interventional Cardiology, Andreas Grüntzig Catheterization Laboratories, Raemistrasse 100 University Hospital Zurich, 8091 Zurich, Switzerland, Phone: +41 1 255 8762, [email protected]
Sponsor: Straub Medical AG, Straubstrasse, 73 23 Wangs, Schweiz
August 29, 2005
I. BACKGROUND AND SIGNIFICANCE
A) Historical Background
Acute pulmonary embolism (PE) is a potentially life-threatening disease with an overall 3-month mortality rate that exceeds 15%, with right ventricular (RV) dysfunction as the most common cause of death (1). The 30-day mortality rate in patients with massive PE, defined as cardiogenic shock or a systemic systolic pressure < 90 mm Hg, exceeds 30%. In patients with massive PE, systemic thrombolysis (2) or surgical embolectomy (3-5) in addition to anticoagulation may be life-saving, facilitating rapid reversal of RV failure and cardiogenic shock. Catheter-directed thrombolysis aims to accelerate clot lysis and achieve rapid reperfusion of pulmonary arteries (6). Rapid recanalization of pulmonary arteries by thrombolysis (7,8) or embolectomy (4) may improve functional class, decrease the risk of recurrence, and prevent chronic thromboembolic pulmonary hypertension. However, approximately 35% patients are not eligible for thrombolysis because of major contraindications, such as recent surgery, trauma, or cancer (9). PE thrombolysis is accompanied by a particularly high risk of bleeding complications. Among 304 patients from t
Sponsor: Straub Medical AG
Current Primary Outcome:
- Immediate decrease in mean pulmonary artery pressure
- Technical success
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Improved flow in the treated main and lobar pulmonary arteries
- In-hospital mortality will not exceed 20%
Original Secondary Outcome: Same as current
Information By: Straub Medical AG
Dates:
Date Received: April 11, 2006
Date Started: October 2005
Date Completion: April 2007
Last Updated: August 6, 2009
Last Verified: August 2009
