Post Pulmonary Embolism In Patients Treated With Catheter Based Therapy

NCT07885787 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 04-2026-100541
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Pulmonary Embolism Acute

Keywords

P.E; CDT

Outcome Measures

Primary Outcomes (2)

• 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.

  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) 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

  6 months

Secondary Outcomes (3)

• Occurence of intracranial hemorrhage

  at the sooner of discharge or 7 days after the randomization

• Major bleeding according to the ISTH definition in non-surgical subjects

  at the sooner of discharge or 7 days after the randomization

• Clinical deterioration and escalation to a bailout therapy

  at the sooner of discharge or 7 days after the randomization

Study Arms (2)

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.

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.

Interventions

The Indigo aspiration system DEVICE

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

Catheter based therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university heart hospital

Asyut, Egypt

Location

Study Officials

• Ahmed A Abdelrady, Master of science

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Abdelrady, Master of science

CONTACT

+2001011835549; Ahmedabdelnaserabdelrady@gmail.com

Ayman K Mohamed, MD

CONTACT

+2001007001091; ayman.hassan@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)