## Protocol Section
### Identification Module
**NCT ID:** NCT03966079

**Acronym:** STEP

**Brief Title:** Thrombolysis Endovascular Treatment of Pulmonary Embolism

**Official Title:** Single-dose rtPA Thrombolysis Endovascular Treatment of Pulmonary Embolism With Right Ventricular Dysfunction:a Pilot Study

#### Organization Study ID Info
**ID:** BeijingTCGH
#### Organization
**Class:** OTHER
**Full Name:** Beijing Tsinghua Chang Gung Hospital
### Status Module
#### Completion Date
**Date:** 2020-01-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-11-30

**Type:** ACTUAL

**Last Update Submit Date:** 2020-11-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-01-31

**Type:** ACTUAL

#### Start Date
**Date:** 2017-01-01

**Type:** ACTUAL

**Status Verified Date:** 2020-11

#### Study First Post Date
**Date:** 2019-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2019-05-20
**Study First Submit QC Date:** 2019-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Tsinghua Chang Gung Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pulmonary Embolism

- Acute Pulmonary Embolism

**Keywords:**

- Acute Pulmonary Embolism

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Prospective Single Group Assignment

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter

**Intervention Names:**

- Drug: recombinant tissue plasminogen activator

**Label:** Intervention arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention arm

**Description:** Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter

**Name:** recombinant tissue plasminogen activator

**Other Names:**

- rtPA

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Change of RV to LV Diameter Ratio

**Time Frame:** baseline and 30days after baseline

#### Secondary Outcomes

**Measure:** Rate of death

**Time Frame:** 30days

**Measure:** Rate of major Bleeding

**Time Frame:** 30days

**Measure:** Pulmonary embolism recurrence

**Time Frame:** 30days

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** Beijing Tsinghua Chang Gung Hospital

**State:** Beijing

**Zip:** 102218

#### Overall Officials

**Official 1:**

**Affiliation:** Director of department

**Name:** Wu weiwei, doctor

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000016769

- Term: Embolism and Thrombosis

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M20824

- Name: Ventricular Dysfunction

- Relevance: LOW

- As Found: Unknown

- ID: M20601

- Name: Ventricular Dysfunction, Right

- Relevance: LOW

- As Found: Unknown

- ID: M14509

- Name: Pulmonary Embolism

- Relevance: HIGH

- As Found: Pulmonary Embolism

- ID: M7784

- Name: Embolism

- Relevance: HIGH

- As Found: Embolism

- ID: M16686

- Name: Thrombosis

- Relevance: LOW

- As Found: Unknown

- ID: M19128

- Name: Embolism and Thrombosis

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011655

- Term: Pulmonary Embolism

- ID: D000004617

- Term: Embolism

### Intervention Browse Module - Ancestors

- ID: D000005343

- Term: Fibrinolytic Agents

- ID: D000050299

- Term: Fibrin Modulating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: FiAg

- Name: Fibrinolytic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M13848

- Name: Plasminogen

- Relevance: HIGH

- As Found: Defibrillator

- ID: M13849

- Name: Tissue Plasminogen Activator

- Relevance: HIGH

- As Found: Respiration

- ID: M8473

- Name: Fibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000010958

- Term: Plasminogen

- ID: D000010959

- Term: Tissue Plasminogen Activator

### Misc Info Module

- Version Holder: 2024-05-24
