BIOLUX P-I First in Man Study

Atherosclerosis Clinical Trial

Official title:

A Prospective, Multi-centre, Randomized Controlled, First in Man Study to Assess the Safety and Performance of the Passeo-18 Lux Paclitaxel Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Patients With Stenosis and Occlusion of the Femoropopliteal Arteries (BIOLUX P-I).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221610
• Other study ID #: C1003
• Status: Completed
• Phase: N/A
• First received: October 14, 2010
• Last updated: February 6, 2015
• Start date: October 2010
• Est. completion date: January 2013

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 Safety
• Study type: Interventional

Clinical Trial Summary

A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Age = 50 years,

2. Informed consent signed by patient prior to randomization

3. Single or sequential de novo or restenotic lesions (stenosis = 70% diameter reduction or occlusion) in the femoropopliteal arteries = 30 mm and = 200 mm long

4. Rutherford Class 2 - 5 in the target limb

5. Reference Vessel Diameter (RVD) 3 - 7 mm, based on visual estimation

6. Inflow free from flow-limiting lesion (< 50% stenosis) confirmed by angiography. Patients with flow-limiting inflow lesions (> 50% stenosis) can be included if lesion has been treated successfully before the index procedure

7. At least one non-occluded crural vessel (eg without significant stenosis) with angiographically documented run-off to the foot

8. Successful wire crossing of the lesion

9. Willingness to comply with all specified follow-up evaluations

10. Male or negative pregnancy test of women in childbearing age

Exclusion Criteria:

1. Co-morbid conditions limiting life expectancy = 1 year

2. Patient currently participating in another clinical trial

3. Lesions which are untreatable with PTA or other interventional techniques

4. The target stenosis is located distal to a stenosis = 50% that cannot be pre-treated because the drug coating could get lost during crossing the proximal lesion

5. Thrombus in the target vessel, documented by angiography

6. Target lesion is severely calcified, documented by angiography

7. Prior bypass surgery of target vessel

8. Previously implanted stent in the target lesion

9. Treatment of bifurcation required

10. Planned amputation of the target limb

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

12. Failure to obtain <30% residual stenosis in a pre-existing haemodynamically significant (>50% DS) inflow lesion in the ipsilateral iliac or proximal SFA. (DEB or DES not allowed for the treatment of inflow lesion)

13. Additional hemodynamically relevant proximal and distal lesions with stenosis = 50 %, except iliac arteries, are excluded. Iliac artery lesion treatments have to be successful with a residual stenosis = 30 %

14. Haemorrhagic diathesis or another disorder such as gastrointestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anticoagulation therapy

15. Phenprocoumon intake

16. Impaired renal function (creatinine = 2.0 - 2.5 mg/dl), according to investigator assessment

17. Known allergy to contrast media that cannot be adequately controlled with pre-medication

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

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	AKH Wien, Kardiovaskuläre und Interventionelle Radiologie	Vienna
Germany	Universitäts-Herzzentrum Freiburg Bad Krozingen	Bad Krozingen
Germany	Gefaesszentrum Berlin, Medizinische Klinik, Ev. Krankenhaus Königin Elisabeth Herzberge	Berlin
Germany	Parkkrankenhaus Leipzig Südost GmbH	Leipzig
Germany	Institut für diagnostische und interventionelle Radiologie, Klinikum Rosenheim	Rosenheim

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA).		6 months	No
Secondary	6 months binary restenosis rate		6 months	No
Secondary	6 months and 12 months TLR rate		6 and 12 months	No
Secondary	6 months and 12 months change in mean ABI		6 and 12 months	No
Secondary	6 months and 12 months change in Rutherford class		6 and 12 months	No
Secondary	Major Adverse Event rate at 6 and 12 months (procedure- or device-related death or amputation, target lesion thrombosis and clinically driven TLR)		6 and 12 months	Yes