LEVANT Japan Clinical Trial

Femoral Artery Occlusion Clinical Trial

Official title:

A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB Versus Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816412
• Other study ID #: MD02-LDCB
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2013
• Last updated: September 27, 2016
• Start date: March 2013
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: MHLW LEVANT Japan study is conducted according to Declaration of Helsinki, Standards stipulated in Article 14, Paragraph 3 & Article 80-2 of the PAL, and Medical Device GCP Ministerial Ordinance".
• Study type: Interventional

Clinical Trial Summary

To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of the femoral and popliteal arteries in the Japanese population.

Description:

The study will enroll patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful protocol-defined pre-dilatation, subjects that are determined not to require stenting based on defined angiographic criteria are randomized 2:1 to treatment with either MD02-LDCB (test arm) or standard PTA catheter (control arm) using similar techniques. Subjects that do not meet post-predilatation lesion criteria are excluded (and treated per standard practice) and followed for safety for 30 days. Randomized subjects will have ultrasound follow-up through 2 years and are consented for up to 2 years clinical follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

• Male or non-pregnant female =20 years of age;

• Rutherford Clinical Category 2-4;

• Length =15 cm;

• =70% stenosis

• Lesion location starts =1 cm below the common femoral bifurcation and terminates distally =2 cm below the tibial plateau AND =1 cm above the origin of the TP trunk;

• A patent inflow artery as confirmed by angiography

• At least one patent native outflow artery to the ankle

Exclusion Criteria:

• Life expectancy of < 2 years;

• History of hemorrhagic stroke within 3 months;

• Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;

• History of MI, thrombolysis or angina within 2 weeks of enrollment;

• Renal failure or chronic kidney disease

• Severe calcification that renders the lesion un-dilatable

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Femoral Arterial Stenosis
• Femoral Artery Occlusion
• Occlusion of Popliteal Arteries
• Stenosis of Popliteal Arteries

Intervention

Device:
• MD02-LDCB Paclitaxel coated balloon catheter

Procedure:
• Standard Uncoated Balloon Angioplasty Catheter

Locations

Country	Name	City	State
Japan	Kansai Rosai Hospital.	Amagasaki-shi	Hyogo-ken.

Sponsors (2)

Lead Sponsor	Collaborator
C. R. Bard	Medicon, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of freedom from all-cause peri-operative (=30 day) death and freedom at 6 months from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.	Primary Patency	6 months	Yes
Secondary	Safety	Composite of freedom from all-cause peri-operative (=30 day) death and freedom at 6 months from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.	1, 3, 6, 12 and 24 months	No
Secondary	Efficacy	Primary Patency of the target lesion at 6 months. Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) =2.5) and freedom from target lesion revascularization (TLR).	1, 3, 6, 12 and 24 months	No