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

Physician Initiated, Prospective, Non-randomized Belgian Multi-center Trial, Investigating the Safety and Efficacy of the Treatment With the LumINor DCB and The IvolutioN Stent of iVascular in TASC C and D Femoropopliteal Atherosclerotic Disease

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 femoropopliteal lesions. An expected total of 100 patients will be treated in the scope of this study. The lesion is located within the native superficial femoral artery and/or the popliteal artery. Prior to dilatation with the Luminor DCB, pre-dilatation with the Oceanus balloon is mandatory. After dilatation with the Luminor DCB, stenting with the iVolution stent need to be performed. Post-dilatation can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1, 6, 12, 24, 36, 48 and 60 month post-procedure. The primary efficacy endpoint of the study is defined as the freedom from clinically-driven target lesion revascularization (TLR) at 12 months. Secondary endpoints include primary patency rate at 6 and 12 months, freedom from clinically-driven TLR at 6, 24, 36, 48 and 60 months, clinical success at 1, 6, 12, 24, 36, 48 and 60 months and freedom from serious adverse events at pre-discharge, 1, 6, 12, 24, 36, 48 and 60 months follow-up.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Combination therapy DCB + stent

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-certification and according to the indications of the Instructions for use (IFU) with focus on the treatment of TASC C and D femoropopliteal atherosclerotic lesions.

Patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should also be geographically stable, willing and able to cooperate in this clinical study and remain available for long-term follow-up. A patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.

Prior to the index procedure the following tests and clinical data will be collected: informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of chronic limb ischemia (Rutherford category) and resting ankle-brachial index (ABI).

During the procedure, the vascular access can be achieved to the investigator's standard clinical practice. After successful lesion passage, diagnostic angiography of the lesion area and distal run-off is performed and angiographic measurements (vessel diameter, percentage stenosis and lesion length) are collected. All inflow-limiting lesion will be treated according to the investigators standard clinical practice before treatment of the target lesion. Pre-dilatation of the target lesion is mandatory with the Oceanus balloon. After pre-dilatation, a least one Luminor DCB will be inflated and at least 1 iVolution stent will be deployed at the target lesion. At the physician's discretion, post-dilatation can be performed. No other adjunctive therapies (atherectomy, laser) are allowed. The complete femoropopliteal vasculature should be treated in one single session, staged interventions are not allowed. All outflow-limiting lesions must be treated according to the hospital treatment standard.

The regular follow-ups are necessary to monitor the condition of the patient and the procedure. Patients will be invited for a follow-up visit at 1, 6, 12, 24, 36, 48 and 60 months after the index procedure. The 24, 36, 48 and 60 month follow-up can be conducted via a phone call. The following data will be collected during these follow-up visit: medication record, physical examination, rutherford categorization, ABI and color flow doppler ultrasound.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • O.L.V. Hospital
  • Antwerpen, Belgium, 2060
    • Z.N.A.
  • Bonheiden, Belgium, 2820
    • Imelda Hospital
  • Bornem, Belgium
    • Sint-Jozefkliniek
  • Dendermonde, Belgium, 9200
    • A.Z. Sint-Blasius
  • Lier, Belgium
    • H. Hartziekenhuis
  • Oostende, Belgium
    • AZ Damiaan
  • Tienen, Belgium, 3300
    • R.Z. Heilig Hart
  • Vilvoorde, Belgium
    • AZ Jan Portaels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination therapy DCB + stent; Patients treated with the Luminor DCB and the iVolution stent	Device: Combination therapy DCB + stent; Patients will be treated with the Luminor DCB and iVolution stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from clinically-driven TLR at 12 months	TLR defined as a repeated intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge at the respective time points.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency rate	Absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.5) at the target lesion and without TLR within the time of the procedure and the given follow-up.	6 and 12 months post-procedure
Technical success	Ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%	Index procedure
Freedom from clinically-driven TLR	TLR defined as a repeated intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge at the respective time points.	6, 24, 36, 48 and 60 months post-procedure
Clinical success	Improvement of Rutherford classification compared to the pre-procedure Rutherford classification	1, 6, 12, 24, 36, 48 and 60 months post-procedure
Serious Adverse Events (SAEs)	Defined according to the Internal Organization of Standardization (ISO) guidelines: ISO 14155:2011	1, 6, 12, 24, 36, 48 and 60 months post-procedure

Collaborators and Investigators

• Sponsor: ID3 Medical
• Investigators: Study Director: Koen Deloose, M.D., ID3 Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2017
• Primary Completion (Actual): October 16, 2019
• Study Completion (Actual): October 26, 2023

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: ID3-20170628

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No