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

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ClinicalTrials.gov Identifier: NCT02710656
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
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.


Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 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



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

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 ClinicalTrials.gov identifier (NCT number): NCT02710656


Contacts
Contact: Mieke Tempels, MSc +32 11 28 69 35 mieke.tempels@archerresearch.eu

Locations
Belgium
ZNA Stuivenberg Recruiting
Antwerpen, Belgium, 2060
Contact: Peter Goverde, Dr         
AZ Sint-Jan Recruiting
Brugge, Belgium, 8000
Contact: Jan De Letter, Dr.         
ZOL (Ziekenhuis Oost-Limburg) Recruiting
Genk, Belgium, 3600
Contact: Geert Lauwers, Dr.         
Jessa hospital Recruiting
Hasselt, Belgium, 3500
Contact: Jos Vandekerkhof, Dr.         
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Inge Fourneau, Prof. Dr.         
France
CHU Bordeaux Recruiting
Bordeau, France, 33076
Contact: Eric Ducasse, Prof. Dr.         
CHU Cermont-Ferrand Recruiting
Clermont-Ferrand, France
Contact: Eugenio Rosset, Prof. Dr.         
CH Mont-de-Marsan Recruiting
Mont-de-Marsan, France
Contact: Mathieu Poirier, Dr.         
Germany
Klinikum Arnsberg Recruiting
Arnsberg, Germany
Contact: Michael Lichtenberg, Dr.         
Sponsors and Collaborators
Cardionovum GmbH
Archer Research
Investigators
Principal Investigator: Peter Goverde, Dr. ZNA Stuivenberg

Responsible Party: Cardionovum GmbH
ClinicalTrials.gov Identifier: NCT02710656     History of Changes
Other Study ID Numbers: MAGNIFICENT
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cardionovum GmbH:
Atherosclerosis
SFA
Poplitea
Drug coated balloon
Angioplasty
Restenosis
Peripheral artery disease (PAD)

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action