BIOLUX P-II First-in-Man Study to Compare the Passeo-18 Lux DRB Against POBA in Infrapopliteal Arteries

NCT01867736 | Completed DMC

• 1 other identifier: C1102
• Study Type: interventional
• Target: 72
• Locations: 3 countries
• Sites: 6

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 catheter for the treatment of stenosis, restenosis or occlusion of the infrapopliteal arteries.

Conditions

Atherosclerosis; Arteriosclerosis; Vascular Disease; Peripheral Artery Disease

Keywords

Stenosis; Occlusions; Infrapopliteal arteries; Below the knee arteries; PTA; POBA; DRB

Outcome Measures

Primary Outcomes (2)

• Safety: Major adverse event rate (MAE), defined as all cause death, major amputation of target extremity, target lesion thrombosis, target lesion revascularisation (TLR)and target vessel revascularization (TVR) at 30 days.

  30 days

• Performance: Target lesion primary patency rate at 6 months assessed by quantitative vascular angiogram (QVA).

  6 months

Secondary Outcomes (12)

• Target lesion failure, assessed by target lesion revascularization (TLR) rate at 6 months and 12 months

  6 and 12 months

• Target vessel revascularization (TVR) rate at 6 months and 12 months

  6 and 12 months

• Binary re-stenosis rate at 6 months, assessed by QVA

  6 months

• Major adverse event rate, defined as all cause death, major amputation of target extremity, target lesion thrombosis, TLR and TVR at 6 months and 12 months

  6 and 12 months

• Change in mean ABI at discharge, 30 days, 6 months and 12 months

  Discharge, 30 days, 6 months and 12 months

Study Arms (2)

Passeo-18 Lux DRB

EXPERIMENTAL

Passeo-18 Lux Drug Releasing Balloon catheter

Device: Passeo-18 Lux DRB

Standard PTA (POBA)

ACTIVE COMPARATOR

Uncoated Passeo-18 PTA balloon catheter

Device: Standard PTA (POBA)

Interventions

Passeo-18 Lux DRB DEVICE

Also known as: Passeo-18 LUX Drug Releasing PTA Balloon Catheter

Passeo-18 Lux DRB

Standard PTA (POBA) DEVICE

Also known as: Uncoated Passeo-18 PTA balloon catheter

Standard PTA (POBA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (6)

Medical University of Graz

Graz, Austria

Location

Imelda Hospital

Bonheiden, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, Belgium

Location

Universitäts-Herzzentrum Freiburg

Bad Krozingen, Germany

Location

Gefaesszentrum Berlin, Medizinische Klinik, Ev. Krankenhaus Königin Elisabeth Herzberge

Berlin, Germany

Location

Parkkrankenhaus Leipzig Südost GmbH

Leipzig, Germany

Location

MeSH Terms

Conditions

Atherosclerosis; Arteriosclerosis; Vascular Diseases; Peripheral Arterial Disease; Constriction, Pathologic; Bites and Stings

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Thomas Zeller, MD

  Universitäts-Herzzentrum Freiburg - Bad Krozingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: June 4, 2013
• Study Start: July 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

BE (2); DE (3); AU (1)