Pulmonary Embolism AcutePE/CBTNCT07885787
Post Pulmonary Embolism In Patients Treated With Catheter Based Therapy
A study testing The Indigo aspiration system in people with Pulmonary Embolism Acute, run by Assiut University at 1 site in Egypt.
Trial summary
Comparing the effects of the mechanical thrombectomy versus medical treatment alone on development and severity of post pulmonary embolism syndrome. To define predictors of post pulmonary embolism syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Embolism Acute
- What is being tested?
- The Indigo aspiration system
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2026to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old.
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less.
- Objectively confirmed acute PE, based on CTPA imaging showing a filling defect in at least one main or proximal lobar pulmonary artery.
- Category E patients according to AHA recent guidelines for management of P.E including patients with cardiopulmonary failure states (either cardiac arrest, refractory cardiogenic shock or recurrent or persistent hypotension with cardiogenic shock).
- Category D patients (i.e patients with incipient cardiopulmonary failure) including normotensive shock with marker of decreased perfusion or end-organ dysfunction (eg, acute ischemic kidney injury, persistently elevated lactate) accompanied by transient hypotension and patients with transient or recurrent hypotension (including relative hypotension compared with the patient's baseline blood pressure) that is short-lived or responds to volume expansion and not accompanied by any signs of reduced perfusion or end-organ dysfunction.
- Category C2,C3 patients with symptomatic disease with increased risk of adverse outcomes by validated severity index and either abnormal RV or abnormal cardiac biomarkers or both.
- Femoral access deemed suitable for mechanical thrombectomy.
- Informed consent is obtained from either the patient or legally authorized representative.
Who cannot join
- Category A patients including asymptomatic and incidentally diagnosed PE cases.
- Category B patients with symptomatic acute PE and low risk of adverse outcomes by validated severity indices.
- Category C1 patients with symptomatic disease with increased risk of adverse outcomes by validated severity index with normal RV and normal cardiac biomarkers.
- History or imaging findings consistent with CTEPH or CTEPD diagnosis.
- Any known contraindication to anticoagulation including allergy, hypersensitivity, or heparin induced thrombocytopenia.
- Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated.
- Active bleeding or disorders contraindicating anticoagulant therapy.
- Platelets <50,000/µL.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Post Pulmonary Embolism Functional Status And Quality Of Life In Patients Treated With Catheter Based Therapy
Comparing the effects of the mechanical thrombectomy versus medical treatment alone on development and severity of post pulmonary embolism syndrome.
To define predictors of post pulmonary embolism syndrome. Incidence of category D and category E pulmonary embolism among P.E patients presenting by hemodynamic compromise.
Correlation with NEWS risk score (Respiratory rate, oxygen saturation, temperature, systolic blood pressure, heart rate, level of consciousness, and need for supplemental oxygen).
Read the detailed description
Despite advances in care, by some estimates, pulmonary embolism (PE) remains the third leading cause of cardiovascular death.
The AHA/ACC Acute PE Clinical Categories are designed to describe the severity and prognosis of PE by integrating various clinical, laboratory, and imaging parameters. The least severe category, Category A, focuses on asymptomatic and incidentally diagnosed PE. Patients with Category A acute PE are typically identified on a CT performed for another indication and in the absence of clinical suspicion of PE. Category B focuses on patients with symptomatic acute PE and low risk of adverse outcomes by validated severity indices (eg, PESI [Pulmonary Embolism Severity Index] ≤85, simplified PESI [sPESI] <1, Hestia <1). Category C focuses on symptomatic disease with increased risk of adverse outcomes by validated severity index (eg, PESI >85, sPESI ≥1, Hestia ≥1).
Category D focuses on pre-cardiopulmonary failure states, such as normotensive shock or approaching need for ventilatory support. The most severe category, Category E, focuses on cardiopulmonary failure states. The subcategories differentiate patients with recurrent or persistent hypotension (hemodynamic collapse) with cardiogenic shock from patients with refractory cardiogenic shock or cardiac arrest.
Follow-up studies demonstrated that after an episode of acute PE, up to half of patients report a functional limitation and a decreased quality of life, which also have been increasingly recognized as long-term complications of acute PE. The concept of post-Pulmonary Embolism syndrome (post-PE syndrome) has been recently introduced and is being increasingly recognized as a long-term sequel of PE .
The post-PE syndrome (PPES) includes chronic thromboembolic pulmonary hypertension (CTEPH), chronic thromboembolic pulmonary disease, post-PE cardiac impairment (characterized as persistent right ventricle impairment after PE), and post-PE functional impairment.
Treatment of PE entails anticoagulation as the first-line therapy with thrombolysis reserved for patients with hemodynamic instability. However, given the severe acute and chronic consequences of PE, there has been an increase in the development of catheter-based therapies (CBTs), including catheter-directed thrombolysis (CDT) and percutaneous mechanical thrombectomy (MT), in order to provide rapid reperfusion. Currently, guidelines recommend CBT for patients with high-risk PE at high bleeding risk or have contraindications or failed systemic thrombolysis.
Catheter-directed interventions for patients with acute pulmonary embolism (PE) are rapidly evolving. Currently, the Food and Drug Administration (FDA) has cleared three interventional devices for use in the treatment of acute PE: the EKOS system (EKOS Corporation, Bothell, WA) in 2014, the FlowTriever System (Inari Medical, Irvine, CA, USA) in 2018 and the Penumbra Indigo aspiration system (Penumbra Inc., Alameda, CA, USA) in 2019.
Penumbra Indigo aspiration system is a suction embolectomy device that has the advantage of rapid thrombus removal without the increased bleeding risk associated with thrombolysis. It consists of a flexible small-bore aspiration catheter (8F \& 12F) connected to a continuous aspiration system that generates a continuous aspiration power of -28.5 inHg. The device also employs a separator wire which helps in clot breakdown to facilitate aspiration.
The Lightning aspiration tubing is a part of the Penumbra Indigo aspiration system that has dual pressure sensors with a built-in microprocessor for real-time blood flow monitoring to provide procedural feedback using audiovisual cues, designed to reduce blood loss. It received FDA clearance in April 2020.
While has been proven to be safe in clinical trials, There is no randomized trials to compare this device with medical therapy alone on post pulmonary embolism syndrome.
- Conditions
- Pulmonary Embolism Acute
- Being tested
- The Indigo aspiration system
- Keywords
- P.E, CDT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Indigo aspiration systemDevice
The Indigo aspiration system (Indigo Aspiration 8-16-F ® System, Penumbra, Alameda, CA, USA) is indicated for use in the peripheral arterial system and the pulmonary arteries, receiving U.S. Food and Drug Administration clearance for PE in December 2019. The PA will be accessed percutaneously, and a diagnostic pulmonary angiogram will be performed to evaluate hemodynamics. The aspiration catheter will be introduced over a 0.035-inch guidewire and advanced to the right or left PA, proximal to the thrombus. Once proximal to the occlusive thrombus, the physician will initiate sustained aspiration with the pump. If appropriate, the separator will be advanced through the catheter to assist with clearing the catheter lumen. Aspiration could be repeated in multiple pulmonary vessels with or without thrombus removal and flushing the catheter between passes. A final pulmonary angiogram and hemodynamic evaluation will be conducted post-Indigo device removal and post procedure
| Study group | Role | What they receive |
|---|---|---|
| Catheter based therapy group | Experimental | The Indigo aspiration system (Indigo Aspiration 8-16-F ® System, Penumbra, Alameda, CA, USA) is indicated for use in the peripheral arterial system and the pulmonary arteries, receiving U.S. Food and Drug Administration clearance for PE in December 2019. The PA will be accessed percutaneously, and a diagnostic pulmonary angiogram will be performed to evaluate hemodynamics. The aspiration catheter will be introduced over a 0.035-inch guidewire and advanced to the right or left PA, proximal to the thrombus. Once proximal to the occlusive thrombus, the physician will initiate sustained aspiration with the pump. If appropriate, the separator will be advanced through the catheter to assist with clearing the catheter lumen. Aspiration could be repeated in multiple pulmonary vessels with or without thrombus removal and flushing the catheter between passes. A final pulmonary angiogram and hemodynamic evaluation will be conducted post-Indigo device removal and post procedure. Receives: Device: The Indigo aspiration system |
| medical treatment alone | No intervention | All patients will receive anticoagulation with either unfractionated heparin (UFH) or low-molecular-weight heparin as determined by the physician in accordance with current guidelines. Patients who will receive low-molecular-weight heparin will have it administered at a weight-/renal-adjusted therapeutic dose. The UFH bolus and infusion will be adjusted to achieve and maintain activated partial thromboplastin time corresponding to therapeutic heparin levels. All patients will be discharged on oral anticoagulation either NOAC or Warfarin for 6 months at least. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of mechanical thrombectomy on Post pulmonary embolism functional limitation at 6 months follow up
Post-PE functional limitation encompasses new or progressive dyspnea and/or exercise intolerance in the absence of other apparent explanations on diagnostic testing apart from PE assessed by Modified Medical Research Council Dyspnea Scale(mMRC) mMRC Dyspnea Scale which measures the severity of breathlessness during daily activities.Grades are Grade 0 (Breathless only with strenuous exercise) Grade 1 (Short of breath when hurrying on level ground or walking up a slight hill) Grade 2 (Walks slower than people of the same age because of breathlessness, or stops when walking at own pace) Grade 3 (Stops for breath after walking about 100 meters or after a few minutes on level ground) Grade 4 (Too breathless to leave the house, or breathless when dressing or undressing) Interpretation: Higher grade = greater functional limitation.
Measured: 6 months
Effectiveness of mechanical thrombectomy on Post pulmonary embolism cardiac impairment at 6 months follow up
Post-PE cardiac impairment is characterized by incomplete RV echocardiographic recovery, as indicated by an intermediate or high echocardiographic probability of pulmonary hypertension (according to the ESC criteria).
Criteria for diagnosis post pulmonary embolism impairment include Clinical Criteria
Assessed ~6 months after acute PE:
Persistent dyspnea (key symptom) Reduced exercise capacity assesed by 6 minutes walk test NYHA functional class ≥ II Unexplained fatigue
± Additional symptoms: Chest discomfort Dizziness / near-syncope Echocardiographic Criteria (Suggestive of PH / CTEPH)
- Elevated pulmonary pressures
- Right ventricular (RV) abnormalities
- RV pressure overload signs
- Right atrial enlargement
- Indirect supportive signs: Dilated pulmonary artery
Measured: 6 months
Secondary outcomes (3)
Occurence of intracranial hemorrhage
Intracranial hemorrhage:
Any bleeding involving the brain parenchyma, ventricular system, or subarachnoid, subdural, or epidural regions as identified by CT scan or MRI regardless of symptoms.
Measured: at the sooner of discharge or 7 days after the randomization
Major bleeding according to the ISTH definition in non-surgical subjects
Major bleeding according to the ISTH definition in non-surgical subjects includes
- Fatal bleeding, AND/OR
- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, AND/OR
- Bleeding causing a fall in hemoglobin level of ≥2 g/dL (1.24 mmol/L) or leading to transfusion of ≥2 units of whole blood or red cells
Measured: at the sooner of discharge or 7 days after the randomization
Clinical deterioration and escalation to a bailout therapy
Clinical deterioration AND/OR escalation to a bailout therapy in
- Clinical deterioration: defined by documented objective hemodynamic or respiratory worsening that is not present at the time of enrollment, including one or more of the following: i. Hypotension with SBP <90 mmHg lasting at least 30 minutes, unresponsive to fluid resuscitation, and requiring the addition of, or increased dose of, vasopressors. ii. Fall in SBP by ≥40 mmHg lasting at least 30 minutes and accompanied end organ hypoperfusion. iii. Cardiac arrest requiring cardiopulmonary resuscitation. iv. Bradycardia lasting >10 minutes, accompanied by hypotension and requiring pharmacologic intervention or insertion of a pacemaker.
- Ventricular tachycardia or fibrillation requiring pharmacologic intervention or defibrillation. vi. Requirement for an increase in fraction of inspired oxygen requirements ≥0.20, lasting longer than 30 minutes. vii. Need for intubation in a previously non-intubated patient.
Measured: at the sooner of discharge or 7 days after the randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism AcuteStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, in addition to receiving anticoagulation, patients will be randomized via closed method with intention to treat principle into 2 groups Group 1: will be treated with mechanical thrombectomy (Indigo Aspiration System, Penumbra, Inc; Supplemental Material) per the instructions for use. The mechanical thrombectomy procedure will be initiated within 24 hours from baseline CTPA and ≤12 hours from randomization. Group 2: will receive anticoagulation only.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Nasser Abdel Rady, Assiut University
- Investigators
- Ahmed A Abdelrady, Master of science, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885787
- Sponsor's protocol ID
- 04-2026-100541
- Acronym
- PE/CBT
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be made publicly available due to patient confidentiality and privacy considerations
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Pulmonary Embolism Functional Status And Quality Of Life In Patients Treated With Catheter Based Therapy
- ClinicalTrials.gov ID
- NCT07885787
- Acronym / sponsor ID
- PE/CBT / 04-2026-100541
- Conditions
- Pulmonary Embolism Acute
- Keywords
- P.E, CDT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing the effects of the mechanical thrombectomy versus medical treatment alone on development and severity of post pulmonary embolism syndrome.
To define predictors of post pulmonary embolism syndrome. Incidence of category D and category E pulmonary embolism among P.E patients presenting by hemodynamic compromise.
Correlation with NEWS risk score (Respiratory rate, oxygen saturation, temperature, systolic blood pressure, heart rate, level of consciousness, and need for supplemental oxygen).
Detailed description
Despite advances in care, by some estimates, pulmonary embolism (PE) remains the third leading cause of cardiovascular death.
The AHA/ACC Acute PE Clinical Categories are designed to describe the severity and prognosis of PE by integrating various clinical, laboratory, and imaging parameters. The least severe category, Category A, focuses on asymptomatic and incidentally diagnosed PE. Patients with Category A acute PE are typically identified on a CT performed for another indication and in the absence of clinical suspicion of PE. Category B focuses on patients with symptomatic acute PE and low risk of adverse outcomes by validated severity indices (eg, PESI [Pulmonary Embolism Severity Index] ≤85, simplified PESI [sPESI] <1, Hestia <1). Category C focuses on symptomatic disease with increased risk of adverse outcomes by validated severity index (eg, PESI >85, sPESI ≥1, Hestia ≥1).
Category D focuses on pre-cardiopulmonary failure states, such as normotensive shock or approaching need for ventilatory support. The most severe category, Category E, focuses on cardiopulmonary failure states. The subcategories differentiate patients with recurrent or persistent hypotension (hemodynamic collapse) with cardiogenic shock from patients with refractory cardiogenic shock or cardiac arrest.
Follow-up studies demonstrated that after an episode of acute PE, up to half of patients report a functional limitation and a decreased quality of life, which also have been increasingly recognized as long-term complications of acute PE. The concept of post-Pulmonary Embolism syndrome (post-PE syndrome) has been recently introduced and is being increasingly recognized as a long-term sequel of PE .
The post-PE syndrome (PPES) includes chronic thromboembolic pulmonary hypertension (CTEPH), chronic thromboembolic pulmonary disease, post-PE cardiac impairment (characterized as persistent right ventricle impairment after PE), and post-PE functional impairment.
Treatment of PE entails anticoagulation as the first-line therapy with thrombolysis reserved for patients with hemodynamic instability. However, given the severe acute and chronic consequences of PE, there has been an increase in the development of catheter-based therapies (CBTs), including catheter-directed thrombolysis (CDT) and percutaneous mechanical thrombectomy (MT), in order to provide rapid reperfusion. Currently, guidelines recommend CBT for patients with high-risk PE at high bleeding risk or have contraindications or failed systemic thrombolysis.
Catheter-directed interventions for patients with acute pulmonary embolism (PE) are rapidly evolving. Currently, the Food and Drug Administration (FDA) has cleared three interventional devices for use in the treatment of acute PE: the EKOS system (EKOS Corporation, Bothell, WA) in 2014, the FlowTriever System (Inari Medical, Irvine, CA, USA) in 2018 and the Penumbra Indigo aspiration system (Penumbra Inc., Alameda, CA, USA) in 2019.
Penumbra Indigo aspiration system is a suction embolectomy device that has the advantage of rapid thrombus removal without the increased bleeding risk associated with thrombolysis. It consists of a flexible small-bore aspiration catheter (8F \& 12F) connected to a continuous aspiration system that generates a continuous aspiration power of -28.5 inHg. The device also employs a separator wire which helps in clot breakdown to facilitate aspiration.
The Lightning aspiration tubing is a part of the Penumbra Indigo aspiration system that has dual pressure sensors with a built-in microprocessor for real-time blood flow monitoring to provide procedural feedback using audiovisual cues, designed to reduce blood loss. It received FDA clearance in April 2020.
While has been proven to be safe in clinical trials, There is no randomized trials to compare this device with medical therapy alone on post pulmonary embolism syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial, in addition to receiving anticoagulation, patients will be randomized via closed method with intention to treat principle into 2 groups Group 1: will be treated with mechanical thrombectomy (Indigo Aspiration System, Penumbra, Inc; Supplemental Material) per the instructions for use. The mechanical thrombectomy procedure will be initiated within 24 hours from baseline CTPA and ≤12 hours from randomization. Group 2: will receive anticoagulation only.
| Arm | Type | Receives |
|---|---|---|
| Catheter based therapy group | Experimental | Device: The Indigo aspiration systemThe Indigo aspiration system (Indigo Aspiration 8-16-F ® System, Penumbra, Alameda, CA, USA) is indicated for use in the peripheral arterial system and the pulmonary arteries, receiving U.S. Food and Drug Administration clearance for PE in December 2019. The PA will be accessed percutaneously, and a diagnostic pulmonary angiogram will be performed to evaluate hemodynamics. The aspiration catheter will be introduced over a 0.035-inch guidewire and advanced to the right or left PA, proximal to the thrombus. Once proximal to the occlusive thrombus, the physician will initiate sustained aspiration with the pump. If appropriate, the separator will be advanced through the catheter to assist with clearing the catheter lumen. Aspiration could be repeated in multiple pulmonary vessels with or without thrombus removal and flushing the catheter between passes. A final pulmonary angiogram and hemodynamic evaluation will be conducted post-Indigo device removal and post procedure. |
| medical treatment alone | No intervention | –All patients will receive anticoagulation with either unfractionated heparin (UFH) or low-molecular-weight heparin as determined by the physician in accordance with current guidelines. Patients who will receive low-molecular-weight heparin will have it administered at a weight-/renal-adjusted therapeutic dose. The UFH bolus and infusion will be adjusted to achieve and maintain activated partial thromboplastin time corresponding to therapeutic heparin levels. All patients will be discharged on oral anticoagulation either NOAC or Warfarin for 6 months at least. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-80 years old.
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less.
- Objectively confirmed acute PE, based on CTPA imaging showing a filling defect in at least one main or proximal lobar pulmonary artery.
- Category E patients according to AHA recent guidelines for management of P.E including patients with cardiopulmonary failure states (either cardiac arrest, refractory cardiogenic shock or recurrent or persistent hypotension with cardiogenic shock).
- Category D patients (i.e patients with incipient cardiopulmonary failure) including normotensive shock with marker of decreased perfusion or end-organ dysfunction (eg, acute ischemic kidney injury, persistently elevated lactate) accompanied by transient hypotension and patients with transient or recurrent hypotension (including relative hypotension compared with the patient's baseline blood pressure) that is short-lived or responds to volume expansion and not accompanied by any signs of reduced perfusion or end-organ dysfunction.
Key exclusion criteria (8 listed)
- Category A patients including asymptomatic and incidentally diagnosed PE cases.
- Category B patients with symptomatic acute PE and low risk of adverse outcomes by validated severity indices.
- Category C1 patients with symptomatic disease with increased risk of adverse outcomes by validated severity index with normal RV and normal cardiac biomarkers.
- History or imaging findings consistent with CTEPH or CTEPD diagnosis.
- Any known contraindication to anticoagulation including allergy, hypersensitivity, or heparin induced thrombocytopenia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Indigo aspiration systemThe Indigo aspiration system (Indigo Aspiration 8-16-F ® System, Penumbra, Alameda, CA, USA) is indicated for use in the peripheral arterial system and the pulmonary arteries, receiving U.S. Food and Drug Administration clearance for PE in December 2019. The PA will be accessed percutaneously, and a diagnostic pulmonary angiogram will be performed to evaluate hemodynamics. The aspiration catheter will be introduced over a 0.035-inch guidewire and advanced to the right or left PA, proximal to the thrombus. Once proximal to the occlusive thrombus, the physician will initiate sustained aspiration with the pump. If appropriate, the separator will be advanced through the catheter to assist with clearing the catheter lumen. Aspiration could be repeated in multiple pulmonary vessels with or without thrombus removal and flushing the catheter between passes. A final pulmonary angiogram and hemodynamic evaluation will be conducted post-Indigo device removal and post procedure | Device | Catheter based therapy group |
Primary outcome
Effectiveness of mechanical thrombectomy on Post pulmonary embolism functional limitation at 6 months follow up
Time frame: 6 months
Post-PE functional limitation encompasses new or progressive dyspnea and/or exercise intolerance in the absence of other apparent explanations on diagnostic testing apart from PE assessed by Modified Medical Research Council Dyspnea Scale(mMRC) mMRC Dyspnea Scale which measures the severity of breathlessness during daily activities.Grades are Grade 0 (Breathless only with strenuous exercise) Grade 1 (Short of breath when hurrying on level ground or walking up a slight hill) Grade 2 (Walks slower than people of the same age because of breathlessness, or stops when walking at own pace) Grade 3 (Stops for breath after walking about 100 meters or after a few minutes on level ground) Grade 4 (Too breathless to leave the house, or breathless when dressing or undressing) Interpretation: Higher grade = greater functional limitation.
Effectiveness of mechanical thrombectomy on Post pulmonary embolism cardiac impairment at 6 months follow up
Time frame: 6 months
Post-PE cardiac impairment is characterized by incomplete RV echocardiographic recovery, as indicated by an intermediate or high echocardiographic probability of pulmonary hypertension (according to the ESC criteria). Criteria for diagnosis post pulmonary embolism impairment include Clinical Criteria Assessed ~6 months after acute PE: Persistent dyspnea (key symptom) Reduced exercise capacity assesed by 6 minutes walk test NYHA functional class ≥ II Unexplained fatigue ± Additional symptoms: Chest discomfort Dizziness / near-syncope Echocardiographic Criteria (Suggestive of PH / CTEPH) 1. Elevated pulmonary pressures 2. Right ventricular (RV) abnormalities 3. RV pressure overload signs 4. Right atrial enlargement 5. Indirect supportive signs: Dilated pulmonary artery
3 secondary outcomes
Occurence of intracranial hemorrhage
Time frame: at the sooner of discharge or 7 days after the randomization
Major bleeding according to the ISTH definition in non-surgical subjects
Time frame: at the sooner of discharge or 7 days after the randomization
Clinical deterioration and escalation to a bailout therapy
Time frame: at the sooner of discharge or 7 days after the randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to patient confidentiality and privacy considerations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed A Abdelrady, Master of science principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Indigo aspiration system in people with Pulmonary Embolism Acute, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Abdelrady, Master of science (+2001011835549, Ahmedabdelnaserabdelrady@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of mechanical thrombectomy on Post pulmonary embolism functional limitation at 6 months follow up (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.