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

NCT03347383 | Completed Results

• 1 other identifier: ID3-20170628
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Freedom From Clinically-driven TLR at 12 Months

  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

  12-month

Secondary Outcomes (5)

• Primary Patency Rate

  6 and 12 months post-procedure

• Technical Success

  Index procedure

• Freedom From Clinically-driven TLR

  6, 24, 36, 48 and 60 months post-procedure

• Clinical Success

  1, 6, 12, 24, 36, 48 and 60 months post-procedure

• Serious Adverse Events (SAEs)

  up to 60 months post-procedure

Study Arms (1)

Combination therapy DCB + stent

EXPERIMENTAL

Patients treated with the Luminor DCB and the iVolution stent

Device: Combination therapy DCB + stent

Interventions

Combination therapy DCB + stent DEVICE

Patients will be treated with the Luminor DCB and iVolution stent

Combination therapy DCB + stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ID3 Medical: lead

Study Sites (9)

O.L.V. Hospital

Aalst, 9300, Belgium

Location

Z.N.A.

Antwerp, 2060, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

Sint-Jozefkliniek

Bornem, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, 9200, Belgium

Location

H. Hartziekenhuis

Lier, Belgium

Location

AZ Damiaan

Ostend, Belgium

Location

R.Z. Heilig Hart

Tienen, 3300, Belgium

Location

AZ Jan Portaels

Vilvoorde, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Results Point of Contact

• Title: Clinical Research Professional
• Organization: iD3 Medical

office@iD3medical.com

+32 (0)52252745

Study Officials

• Koen Deloose, M.D.

  ID3 Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: September 19, 2017
• Primary Completion: October 16, 2019
• Study Completion: October 26, 2023
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2024-10

Locations

BE (9)