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Trial record 19 of 279 for:    Best Disease

BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery

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ClinicalTrials.gov Identifier: NCT03776799
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Dierk Scheinert, University of Leipzig

Brief Summary:
Prospective, multi-center 1:1 randomized trial to compare efficacy and safety of a stent-avoiding (using drug coated balloons) versus a stent-preferred (using drug eluting or interwoven stents) approach for treatment of complex femoropopliteal lesions TASC II (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease) Type B-D (stenosis >10cm, occlusions >5cm; maximum length ≤30cm).

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Stent-avoiding Device: Stent-based Not Applicable

Detailed Description:

Prospective, multi-center 1:1 randomized Study.

Patients will be stratified according to a stent-avoiding (study arm) or stent-preferred (control arm)

In total 120 patient will be enrolled in this study, each strata will include 60 patients.

All enrolled patients will be followed up for 24 month to asses the incidence of restenosis by duplex ultrasound and major adverse events.

Follow-up visits occur at 6, 12 and 24 month intervals as well as telephone visit after 1 month.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery Comparing a Stent-avoiding (Study Arm) Versus Stent-preferred (Control Arm) Approach Within a Prospective, Randomized, Multi-center Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Stent-avoiding approach
using clinically proven drug coated balloons
Device: Stent-avoiding
Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries

Stent-based approach
using drug eluting nitinol stents. Interwoven nitinol stents in heavily calcified lesions at the operator's discretion.
Device: Stent-based
Stenting, in which a stent is advanced and implanted in the obstructed artery, has become the standard endovascular treatment for peripheral arteries




Primary Outcome Measures :
  1. Primary patency - Absence of clinically-driven target lesion revascularization (CD-TLR) and/or restenosis defined as a peak systolic velocity ratio (PSVR) > 2.4 assessed by ultrasound [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. Walking capacity - Walking capacity assessed by Walking impairment questionnaire score at 6, 12 and 24 [ Time Frame: 2 Year ]
    The graded score is multiplied by a pre-specified weight for each distance, speed, or number of stair flights. The products are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficult with any of the tasks)

  2. Ankle-brachial index - Clinical improvment assessed by Ankle-brachial index at 6, 12 and 24 month [ Time Frame: 2 Year ]
    The ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm. An ABI between and including 0.9 and 1.2 considered normal (free from significant PAD), while a lesser than 0.9 indicates arterial disease

  3. Rutherford category - Clinical improvment assessed by Rutherford category at 6, 12 and 24 month [ Time Frame: 2 Year ]

    This classification system consists of four grades and seven categories (categories 0-6):

    Grade 0, Category 0: asymptomatic Grade I, Category 1: mild claudication Grade I, Category 2: moderate claudication Grade I, Category 3: severe claudication Grade II, Category 4: rest pain Grade III, Category 5: minor tissue loss; ischemic ulceration not exceeding ulcer of the digits of the foot Grade IV, Category 6: major tissue loss; severe ischemic ulcers or frank gangrene


  4. Freedom from device and procedure-related death, all-cause death, target limb major amputation and clinically-driven target lesion revascularization [ Time Frame: 2 Years ]


Information from the National Library of Medicine

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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. Subject age ≥ 18
  2. Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
  3. Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
  4. Rutherford Becker Classification 2-4
  5. Both treatment options seem feasible at the operator's discretion
  6. Femoropopliteal lesions classified as TASC II Type B-D with a maximum lesion length ≤ 30cm not involving the infrageniculate popliteal artery are eligible.
  7. Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion. Total lesion length should not exceed 30 cm.
  8. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation.
  9. Patency of at least one (1) infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery. The inflow artery(ies) cannot be treated using a drug eluting stent or drug coated balloon
  10. A guidewire has successfully traversed the target treatment segment.

Exclusion Criteria:

  1. Failure to successfully cross the target lesion
  2. Angiographic evidence of severe calcification that makes a stent-avoiding approach not feasible at the operator's discretion.
  3. Femoropopliteal lesions classified as TASC II Typ A (single stenosis >=10cm and single occlusion >=5cm)
  4. Presence of fresh thrombus in the lesion.
  5. Presence of aneurysm in the target vessel/s
  6. Presence of a stent in the target lesion
  7. Prior vascular surgery of the target lesion.
  8. Stroke or heart attack within 3 months prior to enrollment
  9. Any planned surgical procedure or intervention performed within 30 days prior to or post index procedure
  10. SFA or PPA disease in the opposite leg that requires treatment at the index procedure
  11. Enrolled in another investigational drug, device or biologic study that interferes with the study
  12. Life expectancy of less than one year
  13. Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
  14. Rutherford classification of 0, 1, 5 or 6.
  15. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
  16. Platelet count <100,000 mm3 or >600,000 mm3
  17. Receiving dialysis or immunosuppressant therapy
  18. Pregnant or lactating females.
  19. History of major amputation in the same limb as the target lesion
  20. Chronic kidney disease (serum creatinine > 3 mg/dL)

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): NCT03776799


Contacts
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Contact: Dierk Scheinert, Prof. Dr. +49-341-97 ext 18770 dierk.scheinert@medizin.uni-leipzig.de
Contact: Janin Lenzer +49-341-97 ext 18774 janin.lenzer@medizin.uni.leipzig.de

Locations
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Germany
University Clinic Leipzig Recruiting
Leipzig, Saxony, Germany, 04103
Contact: Janin Lenzer    +49-341-97 ext 18774    janin.lenzer@medizin.uni-leipzig.de   
Principal Investigator: Dierk Scheinert, Prof. Dr.         
Sub-Investigator: Andrej Schmidt, Dr.         
Sub-Investigator: Manuela Matschuck, Dr.         
Sub-Investigator: Corneliu Popescu, Dr.         
Sub-Investigator: Michael Winkfein, Dr.         
Sub-Investigator: Axel Fischer, Dr.         
Sponsors and Collaborators
University of Leipzig
Investigators
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Principal Investigator: Dierk Scheinert, Prof. Dr. University Clinic Leipzig

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Responsible Party: Prof. Dr. Dierk Scheinert, Clinic director, University of Leipzig
ClinicalTrials.gov Identifier: NCT03776799     History of Changes
Other Study ID Numbers: CIP_18/001
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases