Study Comparing Legflow Versus Bare Balloon Angioplasty for Treatment of Atherosclerotic Disease

NCT02710656 | Completed

• 1 other identifier: MAGNIFICENT
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 9

Brief Summary

A randomized multicentric study for endovascular treatment of patients with obstructive disease in the SFA (superficial femoral artery) and in the popliteal artery.

Conditions

Atherosclerosis

Keywords

Atherosclerosis; SFA; Poplitea; Drug coated balloon; Angioplasty; Restenosis; Peripheral artery disease (PAD)

Outcome Measures

Primary Outcomes (1)

• Efficacy measured by binary restenosis rate

  Binary restenosis rate determined by duplex ultrasonography at 1, 6 and 12 months afte procedure. Binary restenosis is defined as a re-obstruction ≥50% of the target lesion (peak systolic velocity ratio \> 2.4).

  Until 12 months after procedure

Secondary Outcomes (7)

• Immediate procedural outcome of percutaneous balloon angioplasty

  From start of procedure surgery until completion of procedure surgery (Percutaneous balloon angioplasty)

• Rutherford

  Baseline until 12 months after procedure

• Mortality

  Until 12 months after procedure

• Repeated target lesion revascularization (TLR) rate

  Until 12 months after procedure

• Repeated target extremity revascularization (TER) rate

  Until 12 months after procedure

Study Arms (2)

Drug Coated Balloon (DCB) - Legflow®

EXPERIMENTAL

Percutaneous balloon angioplasty performed with the investigational device, the paclitaxel eluting Legflow® balloon.

Device: Legflow® balloon

Standard PTA - POBA

ACTIVE COMPARATOR

Percutaneous balloon angioplasty performed with the clinical standard, that is, a non-drug eluting balloon (POBA, plain old balloon angioplasty).

Device: Standard PTA

Interventions

Legflow® balloon DEVICE

Percutaneous angioplasty performed with a Drug coated balloon (DCB) with Paclitaxel

Also known as: Paclitaxel eluting balloon

Drug Coated Balloon (DCB) - Legflow®

Standard PTA DEVICE

Percutaneous angioplasty performed with a standard balloon

Also known as: POBA

Standard PTA - POBA

Eligibility Criteria

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

You may qualify if:

• Patient must sign the informed consent form prior to the index-procedure.
• Patient must be older than 18 years.
• Patient with Rutherford 2, 3 and 4..
• Target lesion is an occlusion or ≥70% stenosis (visual estimate) located in SFA or popliteal artery (P1 -P2).
• Maximum length of the target lesion is 13 cm.
• Target lesion is TASC A, B or C.
• Target lesion is a de novo lesion or restenotic lesion (previously POBA treated, in-stent restenosis is not allowed).
• Inflow arteries are free from hemodynamically significant obstruction (i.e. ≥ 50% diameter stenosis). It is allowed to treat inflow lesions during the index-procedure if the result is ≤ 30% diameter stenosis (treatment with DCB or DES is not allowed). Treatment of a non-target lesion in the target vessel is allowed if the nontarget lesion is considered to be an inflow lesion.
• Popliteal artery P3 segment (below knee popliteal artery) is free from hemodynamically significant obstruction (i.e. ≥ 50%). Treatment of a lesion in this segment is not allowed during the index-procedure.
• At least 1 patent (\< 50% diameter stenosis) below-the-knee vessel (anterior tibial artery, posterior tibial artery or peroneal artery) till the ankle as confirmed by baseline angiography.

You may not qualify if:

• Patient is already included in this study (recruitment of the contralateral leg is not allowed).
• Patient has a known intolerance to antiplatelet therapy or contrast agent.
• Patient with known sensitivity to Paclitaxel.
• Patient is pregnant or patient intends to become pregnant within 1 year after the index-procedure.
• Patient takes esomeprazole or omeprazole.
• Patient with serum creatinine \>2.0 mg/dL or renal dialysis.
• Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
• Patient has a life expectancy \<2 years.
• Patient with Rutherford 0, 1 , 5 and 6.
• Patient has a target lesion that is severely calcified (grade 3 and grade 4).
• Patient with a TASC D lesion.
• Patient has an acute thrombus or aneurysm in the target vessel.
• Patient has a target lesion that cannot be crossed with a guidewire.
• Target vessel has been treated previously with a DCB or a DES.
• Treatment of outflow lesions during the index-procedure.

Sponsors & Collaborators

• Cardionovum GmbH: lead
• Archer Research: collaborator

Study Sites (9)

ZNA Stuivenberg

Antwerp, 2060, Belgium

Location

AZ Sint-Jan

Bruges, 8000, Belgium

Location

ZOL (Ziekenhuis Oost-Limburg)

Genk, 3600, Belgium

Location

Jessa hospital

Hasselt, 3500, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU Bordeaux

Bordeau, 33076, France

Location

CHU Cermont-Ferrand

Clermont-Ferrand, France

Location

CH Mont-de-Marsan

Mont-de-Marsan, France

Location

Klinikum Arnsberg

Arnsberg, Germany

Location

MeSH Terms

Conditions

Atherosclerosis; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Peter Goverde, Dr.

  ZNA Stuivenberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 17, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); FR (3); BE (5)