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

Atherosclerosis Clinical Trial

— BIOLUX P-II  

Official title:

BIOTRONIK's - First in Men Study of the Passeo-18 LUX Drug Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Subjects Requiring Revascularization of Infrapopliteal Arteries (BIOLUX P-II).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867736
• Other study ID #: C1102
• Status: Completed
• Phase: N/A
• First received: May 27, 2013
• Last updated: February 6, 2015
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Vascular Disease
• Vascular Diseases

Intervention

Device:
• Passeo-18 Lux DRB

• Standard PTA (POBA)

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz
Belgium	Imelda Hospital	Bonheiden
Belgium	A.Z. Sint-Blasius	Dendermonde
Germany	Universitäts-Herzzentrum Freiburg	Bad Krozingen
Germany	Gefaesszentrum Berlin, Medizinische Klinik, Ev. Krankenhaus Königin Elisabeth Herzberge	Berlin
Germany	Parkkrankenhaus Leipzig Südost GmbH	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Austria,  Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Performance: Target lesion primary patency rate at 6 months assessed by quantitative vascular angiogram (QVA).		6 months	No
Secondary	Target lesion failure, assessed by target lesion revascularization (TLR) rate at 6 months and 12 months		6 and 12 months	No
Secondary	Target vessel revascularization (TVR) rate at 6 months and 12 months		6 and 12 months	No
Secondary	Binary re-stenosis rate at 6 months, assessed by QVA		6 months	No
Secondary	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	Yes
Secondary	Change in mean ABI at discharge, 30 days, 6 months and 12 months		Discharge, 30 days, 6 months and 12 months	No
Secondary	Change in Rutherford classification at 30 days, 6 months and 12 months		30 days, 6 months and 12 months	No
Secondary	Quality of life evaluation, assessed by EQ5D questionnaire at baseline, 30 days, 6 months and 12 months		Baseline, 30 days, 6 months and 12 months	No
Secondary	Duplex based primary patency at 30 days, 6 months and 12 months		30 days, 6 months and 12 months	No
Secondary	Procedural success, defined as successful vascular access, completion of endovascular procedure and immediate morphologic success with a residual stenosis <30%.		Day 0	No
Secondary	Device success, defined as exact deployment according to Instructions For Use		Day 0	No
Secondary	Technical success, defined as device or procedural success without the occurrence of major adverse events during the hospital stay.		Participants will be followed for the duration of hospital stay, an expected average of 1-2 days	Yes
Secondary	Late Lumen Loss		6-months post-procedure	No