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出境医 / 临床实验 / Thrombolysis Endovascular Treatment of Pulmonary Embolism (STEP)

Thrombolysis Endovascular Treatment of Pulmonary Embolism (STEP)

Study Description
Brief Summary:
To assess the efficacy and safety of endovascular thrombolysis of pulmonary embolism with right ventricular dysfunction with single-dose rtPA

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Acute Pulmonary Embolism Drug: recombinant tissue plasminogen activator Phase 3

Detailed Description:
The patients with right ventricular dysfunction who are diagnosed by CT pulmonary angiography will receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the in this study. The Change of RV to LV Diameter Ratio,Rate of death,rate of major bleeding,pulmonary embolism recurrence at 1month will be reviewed to assess the efficacy and safety.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-dose rtPA Thrombolysis Endovascular Treatment of Pulmonary Embolism With Right Ventricular Dysfunction:a Pilot Study
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : January 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention arm
Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter
 Drug: recombinant tissue plasminogen activator
Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter
Other Name: rtPA
Outcome Measures
Primary Outcome Measures :
  1. Change of RV to LV Diameter Ratio [ Time Frame: baseline and 30days after baseline ]
    Determine whether single-dose rtpa catheter-directed thrombolysis decrease the ratio of right ventricular (RV)-to-left ventricular (LV) diameter within 1month in patients with right ventricular dysfunction


Secondary Outcome Measures :
  1. Rate of death [ Time Frame: 30days ]
  2. Rate of major Bleeding [ Time Frame: 30days ]
  3. Pulmonary embolism recurrence [ Time Frame: 30days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CT evidence of proximal PE
  • Age ≥ 18 years
  • Pulmonary embolism symptom duration ≤14 days
  • Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) OR Submassive PE (RV diameter-to-LV diameter ≥ 0.9 on contrast-enhanced chest CT)

Exclusion Criteria:

  • Age <18 years
  • PE symptom duration >14 days
  • Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
  • Recent (within one month) or active bleeding from a major organ
  • Pregnancy
  • Chronic pulmonary hypertension or severe chronic obstructive pulmonary disease
  • Administration of thrombolytic agents within the previous 3 days
  • Life expectancy < 30 days
  • Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
  • Inability to follow protocol requirements
Contacts and Locations

Locations
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China, Beijing
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing, China, 102218
Sponsors and Collaborators
Beijing Tsinghua Chang Gung Hospital
Investigators
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Study Director: Wu weiwei, doctor Director of department
Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date November 30, 2020
Actual Study Start Date  ICMJE January 1, 2017
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019) 		Change of RV to LV Diameter Ratio [ Time Frame: baseline and 30days after baseline ]
Determine whether single-dose rtpa catheter-directed thrombolysis decrease the ratio of right ventricular (RV)-to-left ventricular (LV) diameter within 1month in patients with right ventricular dysfunction
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • Rate of death [ Time Frame: 30days ]
  • Rate of major Bleeding [ Time Frame: 30days ]
  • Pulmonary embolism recurrence [ Time Frame: 30days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thrombolysis Endovascular Treatment of Pulmonary Embolism
Official Title  ICMJE Single-dose rtPA Thrombolysis Endovascular Treatment of Pulmonary Embolism With Right Ventricular Dysfunction:a Pilot Study
Brief Summary To assess the efficacy and safety of endovascular thrombolysis of pulmonary embolism with right ventricular dysfunction with single-dose rtPA
Detailed Description The patients with right ventricular dysfunction who are diagnosed by CT pulmonary angiography will receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the in this study. The Change of RV to LV Diameter Ratio,Rate of death,rate of major bleeding,pulmonary embolism recurrence at 1month will be reviewed to assess the efficacy and safety.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Embolism
  • Acute Pulmonary Embolism
Intervention  ICMJE Drug: recombinant tissue plasminogen activator
Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter
Other Name: rtPA
Study Arms  ICMJE Experimental: Intervention arm
Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter
Intervention: Drug: recombinant tissue plasminogen activator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 31, 2020
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • CT evidence of proximal PE
  • Age ≥ 18 years
  • Pulmonary embolism symptom duration ≤14 days
  • Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) OR Submassive PE (RV diameter-to-LV diameter ≥ 0.9 on contrast-enhanced chest CT)

Exclusion Criteria:

  • Age <18 years
  • PE symptom duration >14 days
  • Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
  • Recent (within one month) or active bleeding from a major organ
  • Pregnancy
  • Chronic pulmonary hypertension or severe chronic obstructive pulmonary disease
  • Administration of thrombolytic agents within the previous 3 days
  • Life expectancy < 30 days
  • Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
  • Inability to follow protocol requirements
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966079
Other Study ID Numbers  ICMJE BeijingTCGH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beijing Tsinghua Chang Gung Hospital
Study Sponsor  ICMJE Beijing Tsinghua Chang Gung Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wu weiwei, doctor Director of department
PRS Account Beijing Tsinghua Chang Gung Hospital
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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