Try the modernized beta website. Learn more about the modernization effort.
Working… Menu
Trial record 1 of 1 for:    NCT02710656
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02710656
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : January 23, 2020
Archer Research
Information provided by (Responsible Party):
Cardionovum GmbH

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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Device: Legflow® balloon Device: Standard PTA Not Applicable

Detailed Description:

This interventional study will collect data about the treatment of de novo lesions or restenotic lesions. Restenotic lesions that are previously DCB (drug coated balloon) treated or in-stent restenosis are excluded in this study.

The primary objective of this randomized study is to compare the efficacy of the DCB (Legflow - Cardionovum) versus POBA for the treatment of de novo lesions or restenosis in the SFA and in the popliteal artery (segment P1 -P2) by assessing the binary restenosis rate with duplex ultrasonography at 12 months.

The secondary endpoints are the assessment of the immediate procedural outcome, distribution of Rutherford, mortality, target lesion revascularization (TLR), target extremity revascularization (TER), amputation and anklebrachial index (ABI).

For each patient enrolled, data will be collected up to 12 months after the procedure.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Controlled Trial Comparing Legflow - DCB (Cardionovum) Versus Bare Balloon Angioplasty for the Treatment of Atherosclerotic Disease in the Superficial Femoral & Popliteal Segment
Actual Study Start Date : March 2016
Actual Primary Completion Date : October 2019
Actual Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Drug Coated Balloon (DCB) - Legflow®
Percutaneous balloon angioplasty performed with the investigational device, the paclitaxel eluting Legflow® balloon.
Device: Legflow® balloon
Percutaneous angioplasty performed with a Drug coated balloon (DCB) with Paclitaxel
Other Name: Paclitaxel eluting balloon

Active Comparator: Standard PTA - POBA
Percutaneous balloon angioplasty performed with the clinical standard, that is, a non-drug eluting balloon (POBA, plain old balloon angioplasty).
Device: Standard PTA
Percutaneous angioplasty performed with a standard balloon
Other Name: POBA

Primary Outcome Measures :
  1. Efficacy measured by binary restenosis rate [ Time Frame: Until 12 months after procedure ]
    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).

Secondary Outcome Measures :
  1. Immediate procedural outcome of percutaneous balloon angioplasty [ Time Frame: From start of procedure surgery until completion of procedure surgery (Percutaneous balloon angioplasty) ]
    Investigator opinion of procedural and technical success of the percutaneous angioplasty. Opinion of investigator (yes/no) is recorded in the CRF for technical success and procedural success.

  2. Rutherford [ Time Frame: Baseline until 12 months after procedure ]
    Distribution of Rutherford stages during follow-up as compared to baseline.

  3. Mortality [ Time Frame: Until 12 months after procedure ]
    30-day mortality, 6-months mortality and overall mortality at 12 months.

  4. Repeated target lesion revascularization (TLR) rate [ Time Frame: Until 12 months after procedure ]
    TLR is defined as a repeated procedure (endovascular or surgical) due to a problem arising from the lesion (+1 cm proximally and distally to include edge phenomena) initially treated in surviving patients with preserved limb.

  5. Repeated target extremity revascularization (TER) rate [ Time Frame: Until 12 months after procedure ]
    TER is defined as a procedure (endovascular or surgical) due to a problem arising in the ipsilateral traject (iliac, femoropopliteal and below the knee arteries) remote from the lesion initially treated in surviving patients with preserved limb.

  6. Minor and major amputation rate [ Time Frame: Until 12 months after procedure ]
    Occurrence of minor (below the ankle) and major (above the ankle) amputations.

  7. Ankle-Brachial Index (ABI) [ Time Frame: Baseline until 12 months after procedure ]
    Reporting of Ankle-Brachial Index compared to baseline

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient must sign the informed consent form prior to the index-procedure.
  2. Patient must be older than 18 years.
  3. Patient with Rutherford 2, 3 and 4..
  4. Target lesion is an occlusion or ≥70% stenosis (visual estimate) located in SFA or popliteal artery (P1 -P2).
  5. Maximum length of the target lesion is 13 cm.
  6. Target lesion is TASC A, B or C.
  7. Target lesion is a de novo lesion or restenotic lesion (previously POBA treated, in-stent restenosis is not allowed).
  8. 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.
  9. 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.
  10. 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.

Exclusion Criteria:

  1. Patient is already included in this study (recruitment of the contralateral leg is not allowed).
  2. Patient has a known intolerance to antiplatelet therapy or contrast agent.
  3. Patient with known sensitivity to Paclitaxel.
  4. Patient is pregnant or patient intends to become pregnant within 1 year after the index-procedure.
  5. Patient takes esomeprazole or omeprazole.
  6. Patient with serum creatinine >2.0 mg/dL or renal dialysis.
  7. Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
  8. Patient has a life expectancy <2 years.
  9. Patient with Rutherford 0, 1 , 5 and 6.
  10. Patient has a target lesion that is severely calcified (grade 3 and grade 4).
  11. Patient with a TASC D lesion.
  12. Patient has an acute thrombus or aneurysm in the target vessel.
  13. Patient has a target lesion that cannot be crossed with a guidewire.
  14. Target vessel has been treated previously with a DCB or a DES.
  15. Treatment of outflow lesions during the index-procedure.
  16. Patients with significant disease of all 3 infrapopliteal vessels (i.e. ≥ 50% diameter stenosis in each vessel).
  17. Any scheduled surgery within 3 months after the index-procedure that would necessitate the discontinuation of clopidogrel.
  18. Patients with previous bypass surgery involving the SFA.
  19. Patient has cirrhosis of the liver.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02710656

Layout table for location information
ZNA Stuivenberg
Antwerpen, Belgium, 2060
AZ Sint-Jan
Brugge, Belgium, 8000
ZOL (Ziekenhuis Oost-Limburg)
Genk, Belgium, 3600
Jessa hospital
Hasselt, Belgium, 3500
UZ Leuven
Leuven, Belgium, 3000
CHU Bordeaux
Bordeau, France, 33076
CHU Cermont-Ferrand
Clermont-Ferrand, France
CH Mont-de-Marsan
Mont-de-Marsan, France
Klinikum Arnsberg
Arnsberg, Germany
Sponsors and Collaborators
Cardionovum GmbH
Archer Research
Layout table for investigator information
Principal Investigator: Peter Goverde, Dr. ZNA Stuivenberg
Layout table for additonal information
Responsible Party: Cardionovum GmbH Identifier: NCT02710656    
Other Study ID Numbers: MAGNIFICENT
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cardionovum GmbH:
Drug coated balloon
Peripheral artery disease (PAD)
Additional relevant MeSH terms:
Layout table for MeSH terms
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action