Prospective, multicentre single-arm Post-Market Clinical Follow-up (PMCF) study to evaluate safety and performance of the BeYond Venous Self-Expanding Stent
- Conditions
- I80.1I80.2I87.0Phlebitis and thrombophlebitis of femoral veinPhlebitis and thrombophlebitis of other deep vessels of lower extremitiesPostthrombotic syndrome
- Registration Number
- DRKS00024063
- Lead Sponsor
- Bentley InnoMed GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
• Males or non-pregnant females ‚=18 years of age at the time of consent
• Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to treatment
• Willing and capable of complying with all required follow-up visits
• Estimated life expectancy =1 year
• Outpatients (use of assistive walking device such as a cane or walker is acceptable)
• Body mass index (BMI) <35
• As per IFU, clinically significant symptomatic venous outflow obstruction in one iliofemoral venous segment (one limb) per patient, associated by at least one of the following:
- CEAP score =3
- VCSS pain score =2
- Suspected deep vein thrombosis (DVT)
• Subject is willing and able to comply with physician recommendation for compression therapy
• One of the following:
Presence of unilateral, nonmalignant venous obstruction of the common femoral vein, external iliac vein and/or common iliac vein confirmed by venographic or intravascular ultrasound (IVUS) imaging and is indicated for venoplasty and stenting. The cranial point of the obstruction may extend to the iliac vein confluence of the inferior vena cava (IVC) and the caudal point may be 2mm above the inflow of the deep femoral (or profunda) vein or 2mm above the lesser trochanter
• Obstructive target lesion defined as a =50% reduction in target vessel lumen diameter or occluded as confirmed by venography
• Obstructive lesion(s) able to be treated with continuous stent coverage
• Adequate inflow to the target lesion(s) involving a patent femoral or common femoral vein and at least a caudal section of the common femoral vein free from significant disease requiring treatment
• Reference vessel diameter is =10 mm and =18 mm as measured via IVUS or Venography
• All vessels from insertion site through target vessel can accommodate a 10F sheath
• Ability to cross interventional devices through target lesion(s) with successful pre-dilation
• In acute DVT subjects, both onset of symptoms and successful treatment of acute thrombus must have occurred within 14 days prior to receiving study device treatment for an underlying obstructive lesion.
Successful treatment of acute thrombus is defined as =30% residual thrombus (confirmed by venogram or IVUS) and freedom from; bleeding, symptomatic pulmonary embolism (confirmed by imaging) and compromised renal function (defined as GFR <30).
After successful treatment of thrombus is confirmed, study device treatment of eligible obstructive lesion(s) can occur during the same procedure.
• Patients with symptomatic obstructions of the femoral vein or iliac vein, who can be treated according to the following indications listed in the IFU:
- acute iliofemoral deep vein thrombosis
- post-thrombotic syndrome from prior iliofemoral deep vein thrombosis
- Non-thrombotic iliofemoral vein compression such as the May-Thurner syndrome
- Non-thrombotic iliofemoral vein compression such as compression from ectatic or tortuous iliac arteries
• Allergy to nickel titanium alloy (Nitinol)
• Patients with contraindications as listed in the IFU
• Alcohol or drug abuse with maximum daily dose of 12 grams of pure alcohol per day (e.g. 125 ml wine) for women and a maximum of 24 grams (e.g. 250 ml wine) for men. At least two alcohol-free days per week are recommended.
• Target limb symptoms caused by peripheral arterial disease
• Presence or history of clinically significant pulmonary emboli within 180 days prior to enrollment.
• Presence of inferior vena cava (IVC) obstruction or target venous obstruction that extends into IVC and/or IVC filter implantation prior to the index procedure.
• Uncontrolled or active coagulopathy or known, uncorrectable bleeding diathesis
• Uncorrected INR =2.0 or aPTT =1.5 X normal local lab value
• Platelet count <50,000 cells/mm3 or >1,000,000 cells/mm3 and/or White blood cell (WBC) < 3,000 cells/mm3 or > 12,500 cells/mm3
• Uncorrected hemoglobin of = 9 g/dL
• Subject is on dialysis or has an estimated glomerular filtration rate (eGFR) <30 mL/min. In subjects with diabetes mellitus, eGFR <45 mL/min.
• History of Heparin Induced Thrombocytopenia within the 360 days
• Presence of Antiphospholipid Antibody Syndrome (APS)
• Known hypersensitivity or contraindication to antiplatelets or anticoagulation, nickel titanium alloy
• Contrast agent allergy that cannot be managed adequately with pre-medication
• Intended concurrent adjuvant procedure such as creation of temporary arteriovenous fistula, femoral endovenectomy or saphenous vein ablation and/or saphenous vein stripping during the index procedure
• Prior surgical or endovascular procedure of the target vessel with the exception of catheter-directed or mechanical thrombolysis for DVT within 90 days prior to the index procedure or prior venoplasty
• Planned surgical or interventional procedures of the target limb (except thrombolysis and/or thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or 30 days after the index procedure.
• Previous stenting of the target vessel
• Combination / contact of stents from different manufacturers (only combinations of BYV are allowed)
• Iliofemoral venous segment unsuitable for treatment with available sizes of study devices
• Lesions with intended treatment lengths extending into the inferior vena cava
• No safe landing zone above the profunda femoral confluence
• Participating in another investigational study in which the subject has not completed all primary endpoints
• Has other comorbidities that, in the opinion of the investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up assessments
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method