Detour2 Continued Access Study

Not Applicable

Completed

• Conditions: Peripheral Artery Diseases

• 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

Study Timeline

• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-12
• Study Start: 2021-04-07
• Status Verified: 2024-03
• Primary Completion: 2024-05-14
• Study Completion: 2024-05-14
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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.

Trial Locations

Locations (3)

The Vascular Experts; 🇺🇸 Old Saybrook, Connecticut, United States

AMITA Medical Group; 🇺🇸 Elk Grove Village, Illinois, United States

Sentara Norfolk; 🇺🇸 Norfolk, Virginia, United States