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

Not Applicable

Completed

Conditions: Peripheral Arterial Disease

Interventions: Device: Combination therapy DCB + stent

Registration Number: NCT03347383

Lead Sponsor: ID3 Medical

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 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

Inclusion Criteria

Not provided

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combination therapy DCB + stent	Combination therapy DCB + stent	Patients treated with the Luminor DCB and the iVolution stent

Primary Outcome Measures

Name	Time	Method
Freedom From Clinically-driven TLR at 12 Months	12-month	Freedom from clinically-driven TLR at 12 months: 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

Secondary Outcome Measures

Name	Time	Method
Primary Patency Rate	6 and 12 months post-procedure	Primary patency rate at 6-,12-month follow-up; defined as 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 procedure and the given follow-ups
Technical Success	Index procedure	Technical success: defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%
Freedom From Clinically-driven TLR	6, 24, 36, 48 and 60 months post-procedure	Freedom from clinically-driven Target Lesion Revascularisation (CD-TLR) at 6-month, 2-, 3-, 4- and 5-year follow-up; 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
Clinical Success	1, 6, 12, 24, 36, 48 and 60 months post-procedure	Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-, 6-, 12-, 24-, 36-, 48- and 60-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Serious Adverse Events (SAEs)	up to 60 months post-procedure	Serious adverse events as defined per ISO 14155:2011

Trial Locations

Locations (9): Sint-Jozefkliniek
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Bornem, Belgium
AZ Damiaan
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Oostende, Belgium
AZ Jan Portaels
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Vilvoorde, Belgium
O.L.V. Hospital
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Aalst, Belgium
Z.N.A.
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Antwerpen, Belgium
Imelda Hospital
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Bonheiden, Belgium
H. Hartziekenhuis
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Lier, Belgium
A.Z. Sint-Blasius
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Dendermonde, Belgium
R.Z. Heilig Hart
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Tienen, Belgium