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Trial record 1 of 1 for:    NCT02710656
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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 : Completed
First Posted : March 17, 2016
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
Archer Research
Information provided by (Responsible Party):
Cardionovum GmbH

Tracking Information
First Submitted Date  ICMJE March 7, 2016
First Posted Date  ICMJE March 17, 2016
Last Update Posted Date January 23, 2020
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • 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.
  • Rutherford [ Time Frame: Baseline until 12 months after procedure ]
    Distribution of Rutherford stages during follow-up as compared to baseline.
  • Mortality [ Time Frame: Until 12 months after procedure ]
    30-day mortality, 6-months mortality and overall mortality at 12 months.
  • 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.
  • 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.
  • Minor and major amputation rate [ Time Frame: Until 12 months after procedure ]
    Occurrence of minor (below the ankle) and major (above the ankle) amputations.
  • Ankle-Brachial Index (ABI) [ Time Frame: Baseline until 12 months after procedure ]
    Reporting of Ankle-Brachial Index compared to baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Legflow Versus Bare Balloon Angioplasty for Treatment of Atherosclerotic Disease
Official Title  ICMJE Multicenter Randomized Controlled Trial Comparing Legflow - DCB (Cardionovum) Versus Bare Balloon Angioplasty for the Treatment of Atherosclerotic Disease in the Superficial Femoral & Popliteal Segment
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atherosclerosis
Intervention  ICMJE
  • Device: Legflow® balloon
    Percutaneous angioplasty performed with a Drug coated balloon (DCB) with Paclitaxel
    Other Name: Paclitaxel eluting balloon
  • Device: Standard PTA
    Percutaneous angioplasty performed with a standard balloon
    Other Name: POBA
Study Arms  ICMJE
  • Experimental: Drug Coated Balloon (DCB) - Legflow®
    Percutaneous balloon angioplasty performed with the investigational device, the paclitaxel eluting Legflow® balloon.
    Intervention: Device: Legflow® 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).
    Intervention: Device: Standard PTA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2016)
130
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2019
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02710656
Other Study ID Numbers  ICMJE MAGNIFICENT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cardionovum GmbH
Study Sponsor  ICMJE Cardionovum GmbH
Collaborators  ICMJE Archer Research
Investigators  ICMJE
Principal Investigator: Peter Goverde, Dr. ZNA Stuivenberg
PRS Account Cardionovum GmbH
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP