Hancock-Jaffe bioprosthetic venous valve (VenoValve®) for Deep Vein Thrombosis (DVT)

Phase-Based Progress Estimates
Lankenau Medical Center, Wynnewood, PADeep Vein Thrombosis (DVT)Hancock-Jaffe bioprosthetic venous valve (VenoValve®) - Device
All Sexes
What conditions do you have?

Study Summary

This trial is looking at a new valve that can be implanted in people with a specific type of heart valve problem. The aim is to see if it is safe and effective.

Eligible Conditions
  • Deep Vein Thrombosis (DVT)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 3, 6, 12 months and annually thereafter through 5 years

Year 5
Major Adverse Event rates
30 days
The primary safety endpoint is the composite of the following Major Adverse Events

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

75 Total Participants · 1 Treatment Group

Primary Treatment: Hancock-Jaffe bioprosthetic venous valve (VenoValve®) · No Placebo Group · N/A

Experimental Group · 1 Intervention: Hancock-Jaffe bioprosthetic venous valve (VenoValve®) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, 12 months and annually thereafter through 5 years

Who is running the clinical trial?

AXIOM Real Time MetricsUNKNOWN
3 Previous Clinical Trials
670 Total Patients Enrolled
22 Previous Clinical Trials
1,147,308 Total Patients Enrolled
Hancock Jaffe Laboratiores, IncLead Sponsor
Marc Glickman, MDStudy DirectorHancock Jaffe Laboratories, Inc
4 Previous Clinical Trials
666 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 13 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a condition called venous valvular incompetence, which can be caused by issues such as post-thrombotic syndrome.
You are physically able to undergo a duplex ultrasound without discomfort or complications.

Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

Frequently Asked Questions

How many participants are being administered treatment in this trial?

"Affirmative. The clinical trial is currently recruiting for a total of 75 participants across 25 sites, according to the information on clinicialtrials.gov - which was last modified on September 23rd 2022. It was initially posted on August 27th 2021." - Anonymous Online Contributor

Unverified Answer

How many medical centers are conducting this investigation?

"Presently, 25 medical clinics are conducting this trial in cities like Bellevue, Pittsburgh and Buffalo. To ensure minimal travel requirements if you decide to participate, it is recommended that you select the clinic closest to your residence." - Anonymous Online Contributor

Unverified Answer

Is enrollment for this experiment still accepting participants?

"Indeed, the clinicaltrials.gov portal confirms that this study is actively recruiting participants. The trial was first published on August 27th 2021 and has been recently updated to reflect its need for 75 participants at 25 sites across America." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.