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Status:

COMPLETED

Clinical Trial Investigating the Combination Therapy With Luminor DCB and iVolution Stent in TASC C and D Femoropopliteal Lesions

Lead Sponsor:

ID3 Medical

Conditions:

Peripheral Arterial Disease

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The T.I.N.T.I.N. study investigates the safety and efficacy of the combination therapy with the Luminor drug coated balloon (DCB) and the iVolution stent in the treatment of TASC C and D femoropoplite...

Detailed Description

The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term safety and efficacy of the combination therapy with the Luminor DCB and the iVolution stent post CE-...

Eligibility Criteria

Inclusion

  • General inclusion criteria:
  • Patient presenting a score from 2 to 5 following Rutherford classification
  • Patient is willing to comply with specified follow-up evaluations at the specified times
  • Patient is \>18 years old
  • Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
  • Patient has a projected life expectancy of at least 12 months
  • Prior to enrolment, the guidewire has crossed target lesion
  • Patient is eligible for treatment with the Luminor Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter and the iVolution stent
  • Male, infertile female or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
  • Angiographic inclusion criteria
  • De novo and post-percutaneous transluminal angioplasty (PTA) restenotic lesions located in the femoropopliteal arteries suitable for endovascular therapy
  • The target lesion is located within the native femoropopliteal artery
  • The length of the target lesion is ≥ 150mm and considered as TASC C or D lesion according to the TASC II classification.
  • The target lesion has angiographic evidence of stenosis \> 50% or occlusion which can be passed with standard guidewire manipulation
  • Target vessel diameter visually estimated is \>4mm and \<6.5 mm
  • There is angiographic evidence of at least one-vessel-runoff to the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention
  • Exclusion Criteria:
  • Patient refusing treatment
  • Presence of a stent in the target lesion that was placed during a previous procedure
  • Untreated flow-limiting inflow lesions
  • Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
  • Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
  • Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
  • Perforation at the angioplasty site evidenced by extravasation of contrast medium
  • Patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
  • Patients with uncorrected bleeding disorders
  • Aneurysm located at the level of the superficial femoral artery/popliteal artery
  • Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
  • Severe medical comorbidities (severe chronic obstructive pulmonary disease, metastatic malignancy, dementia, etc.) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
  • Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
  • Septicemia or bacteremia
  • Use of thrombectomy, atherectomy or laser devices during procedure
  • Any patient considered to be hemodynamically unstable at onset of procedure
  • Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure

Exclusion

    Key Trial Info

    Start Date :

    September 19 2017

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 26 2023

    Estimated Enrollment :

    100 Patients enrolled

    Trial Details

    Trial ID

    NCT03347383

    Start Date

    September 19 2017

    End Date

    October 26 2023

    Last Update

    March 6 2025

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    O.L.V. Hospital

    Aalst, Belgium, 9300

    2

    Z.N.A.

    Antwerp, Belgium, 2060

    3

    Imelda Hospital

    Bonheiden, Belgium, 2820

    4

    Sint-Jozefkliniek

    Bornem, Belgium