461 Studies Now Enrolling
The DETOUR II Study PQ Bypass System for Femoropopliteal Bypass II
The DETOUR II Study of the PQ Bypass System to Improve Blood Flow to the Legs
| Sponsor: | PQ Bypass, Inc. |
| Enrolling: | Male and Female Patients |
| Study Length: | 3 Years |
| Clinic Visits: | 8 |
| IRB Number: | AAAR8818 |
| U.S. Govt. ID: | NCT03119233 |
| Contact: | Claudia Musat, Study Manager: 212-342-4102 / cm2065@cumc.columbia.edu |
Additional Study Information:
Has your doctor determined that you have Peripheral Arterial Disease (PAD), and that an artery in your upper leg is blocked as a result? Is blood flow to your upper leg(s) blocked?This study will test the safety and effectiveness of the PQ Bypass System (two catheters called the DETOUR Crossing Device and the DETOUR Snare) in improving blood flow to your lower leg. Your doctor can implant the system in your body through surgery done with local anesthesia. This trial will also collect information about the length of your hospital stay and costs associated with treatment using the study device. If you decide to join this study, you will be one of 30 participants at the Columbia University Medical Center and 292 overall at hospitals across the US and Europe. Participation in the study entails a commitment of about 3 years, including the surgical bypass procedure and follow-up visits at approximately 1, 6, 12, 25, and 36 months after discharge from the hospital.
This study is closed
Do You Qualify?
| Are you between 18 and 90 years of age? | Yes | No |
| Can you walk? | Yes | No |
| Do you have Chronic Kidney Disease stage 4 or greater? | Yes | No |
| Do you have a history of deep vein Thrombosis (blood clotting) in either of your legs? | Yes | No |
| In the last 3 months, have you experienced bleeding inside your skull, an aneurysm, a heart attack, or a stroke? | Yes | No |