Trials Sponsors Conditions Drugs Pricing

Conditions

Peripheral Artery Diseases

Outcome Measures

Primary Outcomes (2)

Primary Safety Endpoint at 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.
30 Days
Primary Effectiveness Endpoint - Patency at 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.
12 Months

Study Arms (1)

Single Arm

EXPERIMENTAL

The PQ Bypass system is used during a minimally invasive procedure to place stent grafts in the peripheral vasculature to improve blood flow.

Device: PQ Bypass System

Interventions

PQ Bypass SystemDevice

Intended use from CLN232 Rev A (CLN232 is the DETOUR2 Continued Access Protocol) The PQ Bypass System is intended to improve blood flow in patients with peripheral arterial disease in symptomatic femoropopliteal lesions due to chronic total occlusions ≥ 20 cm that can include de novo, restenotic, or in-stent restenotic lesions; or total lesion lengths ≥24 cm that can include chronic total occlusions or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis.

Single Arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age \> 18 and ≤ 90 years of age.
Willing and able to provide informed consent.

Sponsors & Collaborators

Endologix
Industrylead

Study Sites (3)

The Vascular Experts

Old Saybrook, Connecticut, 06475, United States

AMITA Medical Group

Elk Grove Village, Illinois, 60007, United States

Sentara Norfolk

Norfolk, Virginia, 23502, United States

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Enrollment

11 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 12, 2020

Study Start

April 7, 2021

Actual (reported)

Detour2 Continued Access Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Single Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Single Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations