Detour2 Continued Access Study
- Conditions
- Peripheral Artery Diseases
- Interventions
- Device: PQ Bypass System
- Registration Number
- NCT04625660
- Lead Sponsor
- Endologix
- Brief Summary
Prospective, single-arm, multi-center, clinical investigation to continue to evaluate the safety and effectiveness of the PQ Bypass System to access, deliver guidewires, and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm PQ Bypass System The PQ Bypass system is used during a minimally invasive procedure to place stent grafts in the peripheral vasculature to improve blood flow.
- Primary Outcome Measures
Name Time Method Primary Safety Endpoint at 30 Days 30 Days Freedom from a major adverse event (MAE) at 30 days post-procedure defined as any occurrence of the following events: Death, Clinically-Driven Target Lesion Revascularization (CD-TLR), Major Amputation of the Treated Limb, Symptomatic Deep Vein Thrombosis (DVT), or Pulmonary Embolism, or procedure-related bleeding requiring any transfusion of packed red blood cells or surgery.
Primary Effectiveness Endpoint - Patency at 12 Months 12 Months The absence of clinically-driven target lesion revascularization and absence of recurrent target lesion diameter stenosis \>50% by imaging (e.g., duplex ultrasound peak systolic velocity ratio of \>2.5 or invasive angiography) within the stent or immediately 1 cm above or below the treated segment. When both modalities are available, angiography takes precedence.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
The Vascular Experts
🇺🇸Old Saybrook, Connecticut, United States
Sentara Norfolk
🇺🇸Norfolk, Virginia, United States
AMITA Medical Group
🇺🇸Elk Grove Village, Illinois, United States