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

NCT ID: NCT03347383

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-19
• Study Completion Date: 2023-10-26

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination therapy DCB + stent

Patients treated with the Luminor DCB and the iVolution stent

Group Type: EXPERIMENTAL

Combination therapy DCB + stent

Intervention Type: DEVICE

Patients will be treated with the Luminor DCB and iVolution stent

Interventions

Combination therapy DCB + stent

Patients will be treated with the Luminor DCB and iVolution stent

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ID3 Medical

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Koen Deloose, M.D.

Role: STUDY_DIRECTOR

ID3 Medical

Locations

O.L.V. Hospital

Aalst, , Belgium

Z.N.A.

Antwerp, , Belgium

Imelda Hospital

Bonheiden, , Belgium

Sint-Jozefkliniek

Bornem, , Belgium

A.Z. Sint-Blasius

Dendermonde, , Belgium

H. Hartziekenhuis

Lier, , Belgium

AZ Damiaan

Ostend, , Belgium

R.Z. Heilig Hart

Tienen, , Belgium

AZ Jan Portaels

Vilvoorde, , Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ID3-20170628

Identifier Type: -

Identifier Source: org_study_id