Self-expanding Nitinol Stents of High vs. Low Chronic Outward Force in De-novo Femoropopliteal Occlusive Arterial Lesions

NCT03097679 | Unknown

• 1 other identifier: 1026/2015
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial disease. The BIOFLEX-COF trial is a prospective, randomized controlled trial. 80 subjects will be enrolled and randomly assigned to either a high COF group (LifeStent Vascular Stent) or low COF group (Pulsar).

Conditions

Stent Restenosis; Intimal Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Amount of in-stent restenosis

  Mean amount of in-stent restenosis in percent along the stent axis at one and two years post-procedure.

  one and two years post-procedure

Secondary Outcomes (2)

• Adverse Events ISO 14155:2011

  within two years post-procedure

• Target lesion revascularisation (TLR)

  within two years post-procedure

Study Arms (2)

low COF-group

ACTIVE COMPARATOR

The low COF-group receives a thin-strut stent (Pulsar, Biotronik AG, Bülach, Switzerland) with minimal oversizing (according to manufacturer's Instructions For Use)

Device: Pulsar Stent

high COF-group

ACTIVE COMPARATOR

The high COF-group receives a stiffer-stent (Lifestent Flexstar, Bard Peripheral Vascular Inc., Tempe, AZ, USA) with maximal oversizing (according to manufacturer's Instructions For Use).

Device: LifeStent Flexstar Vascular Stent

Interventions

Pulsar Stent DEVICE

Percutane transluminal stent angioplasty with a Pulsar Stent of the superficial femoral artery for the treatment of peripheral arterial occlusive disease.

low COF-group

LifeStent Flexstar Vascular Stent DEVICE

Percutane transluminal stent angioplasty with a LifeStent Flexstar Vascular Stent of the superficial femoral artery for the treatment of peripheral arterial occlusive disease.

high COF-group

Eligibility Criteria

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

You may qualify if:

• Patient related:
• Subject (or their legal guardian) has read, understood and provided written informed consent, which has been reviewed and approved by the Institutional Review Board.
• At least 18 years of age.
• Male, infertile female or female participants of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7-days prior to study procedure.
• Projected life expectancy of greater than two years.
• The ability to comply with protocol follow-up requirements and required testing.
• Clinical:
• Lifestyle-limiting claudication or CLI (meeting angiographic entry criteria) affecting a lower extremity (Rutherford stages 2-5). Patients with Rutherford stage 2 are only eligible after unsuccessful conventional and/or medicamentous therapy.
• Resting ankle-brachial index (ABI) ≤ 0.8 in the study limb.
• Inflow lesion - if present - has been treated successfully (inflow treatment in same procedure permissible)
• Angiographic and Lesion Requirements (assessed intraoperatively):
• TASC A-D lesions from stenoses /occlusions ≤ 35cm.
• Popliteal artery is patent 5 cm proximal to the radiographic knee joint line.
• Reference diameter of 4.0 - 7.0 mm in proximal and distal treatment segments within the SFA.
• Patent SFA orifice (the proximal 5 mm after femoral bifurcation).

You may not qualify if:

• Pregnant and/or breast-feeding women.
• Lesion length \> 35 cm.
• Flow-limiting occlusive disease of inflow and / or outflow arteries that cannot be treated sufficiently.
• Previous stenting or femoral bypass surgery in the target vessel.
• Clinical relevant aneurysmatic disease of the abdominal aorta, ipsilateral femoral arteries or arteries of the knee.
• Rutherford stage 0, 1 or 6
• Non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis).
• Septicaemia.
• Ischemic stroke within the last three months.
• Any previously known coagulation disorder, including hypercoagulability
• Morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion).
• Contraindication to anticoagulation or antiplatelet therapy.
• Known allergy to medication or contrast media used in this trial, if pre-treatment is not possible (physician's discretion).
• Known allergies to stent components (especially Nickel).
• Severe calcification of the target lesion.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (21)

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  PMID: 29237489 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.univ.

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 31, 2017
• Study Start: October 1, 2015
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)