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

NCT ID: NCT01867736

Last Updated: 2015-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Passeo-18 Lux DRB

Passeo-18 Lux Drug Releasing Balloon catheter

Group Type: EXPERIMENTAL

Passeo-18 Lux DRB

Intervention Type: DEVICE

Standard PTA (POBA)

Uncoated Passeo-18 PTA balloon catheter

Group Type: ACTIVE_COMPARATOR

Standard PTA (POBA)

Intervention Type: DEVICE

Interventions

Passeo-18 Lux DRB

Intervention Type: DEVICE

Standard PTA (POBA)

Intervention Type: DEVICE

Other Intervention Names

Passeo-18 LUX Drug Releasing PTA Balloon Catheter; Uncoated Passeo-18 PTA balloon catheter

Eligibility Criteria

Inclusion Criteria

1. Subject has provided written informed consent.

2. Subject is willing and able to comply with follow-up evaluations.

3. Subject is ≥ 18 years old.

4. 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.

5. A maximum of 2 different vessels can be treated: successful wire crossing is required for the first target vessel before randomization occurs.

6. Subject with PAD or critical limb ischemia according to the current guidelines in need for urgent revascularization to relieve symptoms and improve walking capacity.

7. Reference Vessel Diameter (RVD) 2 - 4 mm, based on visual estimation.

8. 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.

9. At least one non-occluded crural vessel with angiographically documented run-off to the foot.

10. Successful wire crossing of the lesion.

Exclusion Criteria

1. Flow-limiting (> 50% DS) inflow lesion proximal to target lesion, left untreated.

2. 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).

3. Infrapopliteal lesions extending beyond the ankle joint and involving crural vessels.

4. Acute thrombus in the target vessel (eg complication of inflow lesion treatment) documented by angiogram, if not treated successfully prior to enrolment).

5. Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure.

6. Previous bypass surgery of target vessel.

7. Previously implanted stent in target lesion.

8. Haemorrhagic diathesis or coagulopathy or other disorders such as gastrointestinal ulcerations or cerebral disorders that would restrict prescription of dual anti-platelet therapy.

9. Subject with hepatic failure, deep vein thrombosis, thrombophlebitis, systemic lupus erythematous or subject is on immunosuppressant therapy.

10. Subject with acute MI ≤ 3 months.

11. Renal failure with a creatinine of ≥ 2,5 mg/dl, except patients currently on regular dialysis.

12. 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.

13. Known allergy to contrast media used for angiography that cannot be controlled by pre-medication with steroids and/or antihistaminica.

14. Allergy, intolerance or hypersensitivity to Paclitaxel or related compounds and/or to the delivery matrix n-Butyryl tri-n-hexyl citrate(BTHC).

15. Co- morbid conditions limiting life expectancy ≤ 1 year.

16. Patients that are under active treatment for cancer; Patients, who have been successfully treated for cancer in the past, can be included.

17. Subject is participating in another clinical device trial where the primary endpoint has not yet been reached.

18. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Zeller, MD

Role: PRINCIPAL_INVESTIGATOR

Universitäts-Herzzentrum Freiburg - Bad Krozingen, Germany

Locations

Medical University of Graz

Graz, , Austria

Imelda Hospital

Bonheiden, , Belgium

A.Z. Sint-Blasius

Dendermonde, , Belgium

Universitäts-Herzzentrum Freiburg

Bad Krozingen, , Germany

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

Berlin, , Germany

Parkkrankenhaus Leipzig Südost GmbH

Leipzig, , Germany

Countries

Austria; Belgium; Germany

Other Identifiers

C1102

Identifier Type: -

Identifier Source: org_study_id