Recruitment

Recruitment Status
Completed

Inclusion Criteria

Length of the target lesion is ≤ 19 cm by visual estimation and can be covered with one stent
The target lesions are located within the native SFA: distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis
Target vessel diameter visually estimated is ≥4 mm and ≤6 mm
...
Length of the target lesion is ≤ 19 cm by visual estimation and can be covered with one stent
The target lesions are located within the native SFA: distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis
Target vessel diameter visually estimated is ≥4 mm and ≤6 mm
There is angiographic evidence of at least one-vessel-runoff to the foot
The target lesion has angiographic evidence of stenosis >50% or occlusion

Exclusion Criteria

Any planned surgical intervention/procedure 30 days after the study procedure
Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
Perforation at the angioplasty site evidenced by extravasation of contrast medium
...
Any planned surgical intervention/procedure 30 days after the study procedure
Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
Perforation at the angioplasty site evidenced by extravasation of contrast medium
Any patient considered to be hemodynamically unstable at onset of procedure
Previous bypass surgery in the same limb
Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30%
Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint
Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
Patients with uncorrected bleeding disorders
Presence of another stent in the target vessel that was placed during a previous procedure
Life expectancy of less than 12 months
Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
Use of thrombectomy, atherectomy or laser devices during procedure
Patients with known hypersensitivity to nickel-titanium
Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding

Summary

Conditions
Peripheral Vascular Disease
Type
Interventional
Phase
Phase 4
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Ever since its introduction, one of the major limitations of endovascular therapy is the occurrence of restenosis after treatment. Factors contributing to loss of primary patency after percutaneous transluminal angioplasty (PTA) due to balloon injury are negative arterial remodeling, excessive neoin...

Ever since its introduction, one of the major limitations of endovascular therapy is the occurrence of restenosis after treatment. Factors contributing to loss of primary patency after percutaneous transluminal angioplasty (PTA) due to balloon injury are negative arterial remodeling, excessive neointimal proliferation and elastic recoil. In order to increase sustained vessel patency, systemic medication administration and brachytherapy have been proposed, but have not led to any success. With the introduction of stents, patency rates have been optimized also on longer term. However, neointimal hyperplasia after endovascular stent placement in infra-inguinal arteries remains a major limiting issue. Stents themselves contribute to this excessive intimal formation because of the vascular response to the metallic prosthesis. In order to find a solution to overcome this limitation, the possibilities of drug-eluting technologies are being examined. Current concepts include drug-eluting stents (DES), which provide sustained release of anti-proliferative medication into the vessel wall. The application of a drug coating on a stent surface inhibits the inflammatory response and smooth muscle cell proliferation in the vessel wall during a certain period and delays the process of intimal hyperplasia. Thus, DES technology was developed to prevent early restenosis and late luminal loss to potentially improve long-term patency rates. Because DES with active stent coatings have shown to be beneficial in the treatment of coronary artery disease, the technique of active stent coatings (sirolimus or paclitaxel) as commonly used in coronary interventions was transferred to the infrainguinal vascular bed. However, an active stent coating (sirolimus or paclitaxel) only inhibits the inflammatory response and smooth muscle cell proliferation in the vessel wall for a certain period; in fact, it merely delays the process of intimal hyperplasia as demonstrated by the 2-year results of the SIROCCO study. Another novel way of inhibiting restenosis after PTA is the use of drug-coated balloons (DCB), which inhibit restenosis by an immediate local release of medication during the intervention. The rationale behind the use of DCBs is based on the finding that sustained drug elution is not a necessary to obtain a sustained inhibition of restenosis. The concept of using a balloon with medication to treat vascular disease was introduced in 2003 by Scheller et al. One of the most commonly used drugs for arterial applications is the anti-proliferative paclitaxel (Taxol), which impedes cell division in the cell cycle. Paclitaxel has certain characteristics which make it a promising candidate for treatment of peripheral arterial disease. Because it is hydrophobic, paclitaxel does not require the use of a polymer to prevent wash-off during tracking or implantation. Adequate drug delivery to the vessel wall is possible because of its lipophilic characteristic, which enables paclitaxel to interact with the high concentrations of lipids present in the vessel wall and avoids the need for a polymer. Results of preclinical and clinical studies have shown that short-term exposure to Paclitaxel may suffice to obtain a sustained reduction in late lumen loss and avoid restenosis in both coronary and peripheral arteries: in contrast to stents, DCBs do not leave any residual material in the artery lumen that could trigger neointimal proliferation, thus making DCBs an attractive alternative to stents, especially in challenging arterial anatomies. Further investigation is warranted in order to obtain conclusive data. Furthermore, the benefit of treating in-stent restenosis (ISR) in the peripheral arteries with DCBs has yet to be investigated, although limited data is already available to date. The clinical value of these drug-eluting technologies has been proven repeatedly in the coronary arteries, and evidence of therapeutic applications to peripheral artery disease is starting to build. It is the intent of this prospective study to evaluate the treatment of a drug-coated balloon followed by stent implant and comparing this to the results of the 4EVER trial and results in the literature.

Inclusion Criteria

Length of the target lesion is ≤ 19 cm by visual estimation and can be covered with one stent
The target lesions are located within the native SFA: distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis
Target vessel diameter visually estimated is ≥4 mm and ≤6 mm
...
Length of the target lesion is ≤ 19 cm by visual estimation and can be covered with one stent
The target lesions are located within the native SFA: distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis
Target vessel diameter visually estimated is ≥4 mm and ≤6 mm
There is angiographic evidence of at least one-vessel-runoff to the foot
The target lesion has angiographic evidence of stenosis >50% or occlusion

Exclusion Criteria

Any planned surgical intervention/procedure 30 days after the study procedure
Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
Perforation at the angioplasty site evidenced by extravasation of contrast medium
...
Any planned surgical intervention/procedure 30 days after the study procedure
Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
Perforation at the angioplasty site evidenced by extravasation of contrast medium
Any patient considered to be hemodynamically unstable at onset of procedure
Previous bypass surgery in the same limb
Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30%
Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint
Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
Patients with uncorrected bleeding disorders
Presence of another stent in the target vessel that was placed during a previous procedure
Life expectancy of less than 12 months
Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
Use of thrombectomy, atherectomy or laser devices during procedure
Patients with known hypersensitivity to nickel-titanium
Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding

Locations

Dendermonde, 9200
Aalst, 9300
Tienen, 3300
Edegem, Antwerp, 2650
Bonheiden, 2820
...
Dendermonde, 9200
Aalst, 9300
Tienen, 3300
Edegem, Antwerp, 2650
Bonheiden, 2820

Tracking Information

NCT #
NCT02211664
Collaborators
Not Provided
Investigators
Not Provided