CompletedNot Applicable

The Protrieve PROTECTOR Study

United States66 participantsStarted 2025-03-05

Plain-language summary

The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the Protrieve Sheath.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years
✓. Planned intervention for DVT presenting with one or more of the following characteristics indicative of elevated risk for PE:
✓. Bilateral iliofemoral DVT
✓. Clot extending into or located in the IVC
✓. In-stent thrombosis
✓. Presence of thrombosed IVC filter
✓. Other features that the investigator deems put the subject at elevated risk for thromboembolism
✓. Willing and able to provide informed consent

✕. Current symptomatic PE
✕. Known anatomic inability to place Protrieve device via jugular vein access site
✕. Presence of clot extending to the IVC-Right Atrial junction or in the SVC
✕. Subject is pregnant
✕. Severe allergy to iodinated contrast agents that cannot be mitigated
✕. INR \> 1.7 if not currently on anticoagulation therapy, platelets \< 50,000/μl which cannot be corrected prior to enrollment, or Hemoglobin \< 8.0 g/dL
✕. Severe renal impairment in patients who are not yet on dialysis that in the Investigator's discretion would pose risk to the patient with the use of marketed contrast agents
✕. Subject is participating in another study that may interfere with this study

Primary Effectiveness Measure:

Timeframe: 24 Hours (+-12 Hours)

Primary Safety Measure:

Timeframe: 24 Hours (+-12 Hours)

NCT IDNCT06495996

SponsorInari Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-06