Status:
COMPLETED
BIOLUX P-II First-in-Man Study to Compare the Passeo-18 Lux DRB Against POBA in Infrapopliteal Arteries
Lead Sponsor:
Biotronik AG
Conditions:
Atherosclerosis
Arteriosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A prospective, multicentric, randomized controlled trial to assess the safety and performance of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18 PTA balloon c...
Eligibility Criteria
Inclusion
- Subject has provided written informed consent.
- Subject is willing and able to comply with follow-up evaluations.
- Subject is ≥ 18 years old.
- Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries ≥ 30 mm. Lesions should not extend beyond the ankle joint.
- A maximum of 2 different vessels can be treated: successful wire crossing is required for the first target vessel before randomization occurs.
- Subject with PAD or critical limb ischemia according to the current guidelines in need for urgent revascularization to relieve symptoms and improve walking capacity.
- Reference Vessel Diameter (RVD) 2 - 4 mm, based on visual estimation.
- Inflow free from flow-limiting lesion confirmed by angiography. Patients with flow-limiting inflow lesions (\> 50% stenosis) can be included if lesion(s) have been treated successfully before the index procedure, with a maximum residual stenosis of 30% per visual assessment.
- At least one non-occluded crural vessel with angiographically documented run-off to the foot.
- Successful wire crossing of the lesion.
Exclusion
- Flow-limiting (\> 50% DS) inflow lesion proximal to target lesion, left untreated.
- Failure to obtain \<30% residual stenosis in a pre-existing haemodynamically significant (\>50% DS) inflow lesion (DEB or DES not allowed for the treatment of inflow lesions).
- Infrapopliteal lesions extending beyond the ankle joint and involving crural vessels.
- Acute thrombus in the target vessel (eg complication of inflow lesion treatment) documented by angiogram, if not treated successfully prior to enrolment).
- Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure.
- Previous bypass surgery of target vessel.
- Previously implanted stent in target lesion.
- Haemorrhagic diathesis or coagulopathy or other disorders such as gastrointestinal ulcerations or cerebral disorders that would restrict prescription of dual anti-platelet therapy.
- Subject with hepatic failure, deep vein thrombosis, thrombophlebitis, systemic lupus erythematous or subject is on immunosuppressant therapy.
- Subject with acute MI ≤ 3 months.
- Renal failure with a creatinine of ≥ 2,5 mg/dl, except patients currently on regular dialysis.
- Phenprocoumon intake, except for patients who are treated for Arterial Fibrillation. For these patients Phenprocoumon treatment can be interrupted and re-started after treatment with Dual Antiplatelet Therapy for 4 weeks post procedure.
- Known allergy to contrast media used for angiography that cannot be controlled by pre-medication with steroids and/or antihistaminica.
- Allergy, intolerance or hypersensitivity to Paclitaxel or related compounds and/or to the delivery matrix n-Butyryl tri-n-hexyl citrate(BTHC).
- Co- morbid conditions limiting life expectancy ≤ 1 year.
- Patients that are under active treatment for cancer; Patients, who have been successfully treated for cancer in the past, can be included.
- Subject is participating in another clinical device trial where the primary endpoint has not yet been reached.
- Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01867736
Start Date
July 1 2012
End Date
July 1 2014
Last Update
February 9 2015
Active Locations (6)
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1
Medical University of Graz
Graz, Austria
2
Imelda Hospital
Bonheiden, Belgium
3
A.Z. Sint-Blasius
Dendermonde, Belgium
4
Universitäts-Herzzentrum Freiburg
Bad Krozingen, Germany