N/A
Completed N=119
Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
Source: ClinicalTrials.gov NCT03218566 ↗Enrolled (actual)
119
Serious AEs
10.9%
Results posted
Aug 2020
Primary outcomePrimary: Right Ventricle/Left Ventricle (RV:LV) Ratio — 0.43 Change in RV/LV Diameter Ratio
Summary
To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Right Ventricle/Left Ventricle (RV:LV) Ratio |
0.43 | — |
| PRIMARY Major Adverse Event Rate |
2 | — |
| SECONDARY Device-related Death Rate |
1 | — |
| SECONDARY Major Bleeding Rate |
2 | — |
| SECONDARY Clinical Deterioration Rate |
2 | — |
| SECONDARY Pulmonary Vascular Injury Rate |
2 | — |
| SECONDARY Cardiac Injury Rate |
— | — |
| SECONDARY Any-cause Mortality |
3 | — |
| SECONDARY Device-related SAE Rate |
2 | — |
| SECONDARY Symptomatic PE Recurrence Rate |
— | — |
Eligibility Criteria
Inclusion Criteria
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less. Evidence of PE must be from CTA.
- Systolic BP ≥ 90 mmHg with evidence of dilated RV with an RV/LV ratio > 0.9
- Patient is 18 years of age or older
Exclusion Criteria
- tPA use within 14 days prior to baseline CTA
- Systolic BP 70 mmHg by right heart catheterization
- History of severe or chronic pulmonary hypertension
- Fi02 requirement > 40% or >6 LPM to keep oxygen saturations >90%
- Hematocrit 1.8 mg/dL
- INR > 3
- aPTT (or PTT) > 50 seconds on no anticoagulation
- History of heparin-induced thrombocytopenia (HIT)
- Contraindication to systemic or therapeutic doses of anticoagulants
- Major trauma < 14 days
- Presence of intracardiac lead
- Cardiovascular or pulmonary surgery within last 7 days
- Cancer requiring active chemotherapy
- Known serious, uncontrolled sensitivity to radiographic agents
- Life expectancy < 90 days
- Female who is pregnant
- Intracardiac Thrombus
- Patients on ECMO
- Current participation in another investigational study
Data sourced from ClinicalTrials.gov (NCT03218566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.