An interventional study of PQ Bypass System for Femoropopliteal Bypass in Peripheral Arterial Disease, sponsored by Endologix. Completed at 8 sites in 6 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Endologix · Not applicable, Interventional, and Treatment
To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
Prospective, single-arm, multi-center, international, non-randomized, pre-market, safety and effectiveness clinical investigation evaluating the PQ Bypass Systems to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's enrollment of 78 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Endologix is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 9 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Femoro-popliteal lesions ≥10 cm in length considered to be:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PQ Bypass System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass
Device: PQ Bypass System for Femoropopliteal Bypass
To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
Number of Lesions With Primary Patency
Rate of primary patency. Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of \>2.5).
Time frame: 6 Months
Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure
composite endpoint of death, CD-TVR, or major target limb amputation in all patients at One-month post procedure
Time frame: One Month
Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure
Outcome Measures of death, CD-TVR, or major target limb amputation as independent events one month post-procedure
Time frame: One Month
Percentage of Lesions With Primary Patency at 12 Months Post-Procedure
Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of \>2.5).
Time frame: 12 Months
Major Adverse Vascular Event (MAVE) Rate
Major Adverse Vascular Events-stent graft thrombosis, target limb amputation, clinically apparent distal embolization with tissue loss, procedure-related arterial rupture, acute limb ischemia, and bleeding events requiring any transfusion. Major bleeding required blood transfusion \>2 units, and symptomatic deep vein thrombosis on ipsilateral limb
Time frame: One Month
Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb
Rate of Symptomatic Deep Vein Thrombosis in target limb at one month time point.
Time frame: One Month
Number of Major Adverse Events at the 12-Month Time Point
Number of occurrences of all cause death, CD-TVR, or major target limb amputation
Time frame: 12 Months
Number of Major Adverse Events at the 3 Year Time Point
Number of occurrences of all cause death, CD-TVR, or major target limb amputation
Time frame: 3 Years
Major Adverse Vascular Event (MAVE) Rate at 3 Years
Major Adverse Vascular Events-stent graft thrombosis, target limb amputation, clinically apparent distal embolization with tissue loss, procedure-related arterial rupture, acute limb ischemia, and bleeding events requiring any transfusion. Major bleeding required blood transfusion \>2 units, and symptomatic deep vein thrombosis on ipsilateral limb.
Time frame: 3 Years
Technical Success
Technical Success defined as successful delivery of the investigational devices to the identified area and removal of delivery system.
Time frame: Index Procedure
78 patients enrolled over the course of 24 months at 8 investigational sites
| Milestone | Enrolled and Treated Patients |
|---|---|
| Started | 78 |
| 12 month results | 77 |
| Completed | 68 |
| Not completed | 10 |
| Withdrew: Early term withdrawal | 10 |
Rate of primary patency. Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of \>2.5).
| Lesions | Enrolled and Treated Patients |
|---|---|
| Number of Lesions With Primary Patency | 72 |
composite endpoint of death, CD-TVR, or major target limb amputation in all patients at One-month post procedure
| Lesions | Enrolled Cohort |
|---|---|
| MAE | 2 |
| Free from MAE | 79 |
Outcome Measures of death, CD-TVR, or major target limb amputation as independent events one month post-procedure
| Lesions | Enrolled Cohort |
|---|---|
| Death | 0 |
| CD-TVR | 2 |
| Target Limb Amputation | 0 |
| Free from MAE | 79 |
Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of \>2.5).
| percentage of lesions | Enrolled Cohort |
|---|---|
| Percentage of Lesions With Primary Patency at 12 Months Post-Procedure | 81 ± 4 |
Major Adverse Vascular Events-stent graft thrombosis, target limb amputation, clinically apparent distal embolization with tissue loss, procedure-related arterial rupture, acute limb ischemia, and bleeding events requiring any transfusion. Major bleeding required blood transfusion \>2 units, and symptomatic deep vein thrombosis on ipsilateral limb
| Lesions | Enrolled Cohort |
|---|---|
| Stent thrombosis | 3 |
| Clinically apparent distal embolization | 0 |
| Procedure-related arterial rupture | 0 |
| Acute limb ischemia | 0 |
| Bleeding event requiring transfusion | 1 |
| Free from MAVE | 77 |
| Symptomatic Deep Vein Thrombosis on Ipsilateral Limb | 1 |
Rate of Symptomatic Deep Vein Thrombosis in target limb at one month time point.
| Lesions | Enrolled and Treated Patients |
|---|---|
| DVT in Target Limb | 1 |
| Freedom from DVT in Target Limb | 80 |
Number of occurrences of all cause death, CD-TVR, or major target limb amputation
| Events | Enrolled Cohort |
|---|---|
| Death | 1 |
| CD-TVR | 12 |
| Target limb amputation | 0 |
| Freedom from MAE | 66 |
Number of occurrences of all cause death, CD-TVR, or major target limb amputation
| Events | Enrolled Cohort |
|---|---|
| Death | 3 |
| Target limb amputation | 1 |
| CD-TVR | 27 |
Major Adverse Vascular Events-stent graft thrombosis, target limb amputation, clinically apparent distal embolization with tissue loss, procedure-related arterial rupture, acute limb ischemia, and bleeding events requiring any transfusion. Major bleeding required blood transfusion \>2 units, and symptomatic deep vein thrombosis on ipsilateral limb.
| Participants | Enrolled Cohort |
|---|---|
| Stent Graft Thrombosis (absence of TVR) | 15 |
| Clinically Apparent Distal Embolization | 0 |
| Procedure Related Arterial Rupture | 0 |
| Acute Limb Ischemia | 0 |
| Major Blood Loss Related to the PQ Bypass procedure requiring >2 units or packed RBC | 1 |
| Symptomatic Deep Vein Thrombosis on Ipsilateral Limb | 2 |
Technical Success defined as successful delivery of the investigational devices to the identified area and removal of delivery system.
| Lesions | Enrolled and Treated Patients |
|---|---|
| Technical Success | 79 |
Collected over Adverse Events were collected at each follow-up visit through 3 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enrolled and Treated Patients | 3/78 (3.8%) | 14/78 (17.9%) | 65/78 (83.3%) |
| Event | Enrolled and Treated Patients |
|---|---|
| Stent ThrombosisVascular disorders | 13/78 |
| Clinically Driven Target Vessel Revascularization (CD-TVR)Surgical and medical procedures | 12/78 |
| Deep Vein Thrombosis (DVT)Vascular disorders | 2/78 |
| Bleeding event requiring transfusionSurgical and medical procedures | 1/78 |
| Target Limb AmputationSurgical and medical procedures | 0/78 |
| Clinically apparent distal embolizationVascular disorders | 0/78 |
| Procedure-related arterial ruptureVascular disorders | 0/78 |
| Acute limb ischemiaVascular disorders | 0/78 |
| Event | Enrolled and Treated Patients |
|---|---|
| Stent Graft thrombosisVascular disorders | 13/78 |
| Stent Graft StenosisVascular disorders | 10/78 |
| EdemaBlood and lymphatic system disorders | 7/78 |
| Deep Vein ThrombosisVascular disorders | 4/78 |
| RefluxVascular disorders | 4/78 |
| PainGeneral disorders | 4/78 |
| Access site hemorrhage or hematomaVascular disorders | 3/78 |
| Drug ReactionInjury, poisoning and procedural complications | 3/78 |
| FeverGeneral disorders | 3/78 |
| Target Vessel Revascularization (TVR)Vascular disorders | 3/78 |
Overall Number of Baseline Participants enrolled 78, and Overall Number of Lesions (units) analyzed 82.
| Age, Continuous(years) | Enrolled and Treated Patients |
|---|---|
| Mean | 65 ± 7 |
| Sex: Female, Male(Participants) | Enrolled and Treated Patients |
|---|---|
| Female | 13 |
| Male | 65 |
| Race and Ethnicity Not Collected(Participants) | Enrolled and Treated Patients |
|---|
| Region of Enrollment(Lesions) | Enrolled and Treated Patients |
|---|---|
| New Zealand | 1 |
| Latvia | 34 |
| Poland | 36 |
| Italy | 1 |
| Chile | 7 |
| Germany | 3 |
| Hypertension(Participants) | Enrolled and Treated Patients |
|---|---|
| Count of participants | 65 |
| Diabetes mellitus(Participants) | Enrolled and Treated Patients |
|---|---|
| Count of participants | 20 |
| Hypercholesterolemia(Participants) | Enrolled and Treated Patients |
|---|---|
| Count of participants | 31 |
| History of Coronary Artery Disease (CAD)(Participants) | Enrolled and Treated Patients |
|---|---|
| Count of participants | 34 |
9 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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