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About
The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the BeGraft Peripheral Stent Graft System (Bentley InnoMed) in clincial settings post CE-certification when used according to the indications of the IFU.
Full description
Endovascular techniques are well accepted in the treatment of iliac occlusive disease. It is shown that in the iliac artery especially stenoses and short occlusions respond well to percutaneous transluminal angioplasty (PTA) with our without stenting. Although hard data are lacking, with the technical developments and the introduction of new stent types, more complex lesions have been treated with endovascular procedures. Although stents are often used to improve the outcome of PTA, there is no general consensus whether stenting is mandatory for chronic iliac arterial occlusion. The more, if we use stents, it is still unclear if we should implant bare self-expandable stents, bare balloon-expandable stents or covered stents. On one hand, the randomized controlled Dutch Iliac Stenting trial failed in demonstrating superiority of primary stenting over PTA with additional stenting in short lesions. On the other hand, while several papers advocate bare stenting, other trials conclude better results with covered stents.
The Trans-Atlantic Inter-Society Consensus (TASC) working group has published in 2000 their recommendations for the management of peripheral arterial disease. In order to better reflect the developments in technology and techniques, the TASC working group has revised and updated their recommendations in the TASC-II document in 2007.
The treatment recommendations between surgical or percutaneous intervention they propose involve all peripheral arterial beds and are based upon several factors such as availability of expertise in the percutaneous or conventional vascular surgical techniques, the patient's preference and most importantly on the lesion's morphology. TASC classifies all lesions in the different beds into types A to D. In general, endovascular therapy is the treatment of choice for TASC A & B-lesions and surgery is preferred for good-risk patients with TASC C lesions and all TASC D lesions.
For aorto-iliac lesions, the TASC-II classification is as follows:
Type A lesions
Type B lesions
Short (≤3 cm) stenosis of infrarenal aorta.
Unilateral CIA occlusion.
Single or multiple stenosis totaling 3-10 cm involving the EIA not extending into the Common Femoral Artery (CFA)
Unilateral EIA occlusion not involving the origins of Internal Iliac Artery (IIA) or CFA Type C lesions
Bilateral CIA occlusions 2. Bilateral EIA stenoses 3-10 cm long not extending into the CFA 3. Unilateral EIA stenosis extending into the CFA 4. Unilateral EIA occlusion that involves the origins of IIA and/or CFA 5. Heavily calcified unilateral EIA occlusion with or without involvement of origins of IIA and/or CFA Type D lesions
Infra-renal aortoiliac occlusion
Diffuse disease involving the aorta and both iliac arteries requiring treatment
Diffuse multiple stenoses involving the unilateral CIA, EIA and CFA
Unilateral occlusions of both CIA and EIA
Bilateral occlusions of EIA
Iliac stenoses in patients with an Abdominal Aortic Aneurysm (AAA) requiring treatment and not amenable to endograft placement or other lesions requiring open aortic or iliac surgery
The TASC working group has based their recommendations on the literature available to date and are generally considered as the guidelines to be followed. Nevertheless it should be stated that it is feasible to treat with good technical success and sustained durability TASC type C and D lesions in an endovascular way.
Recent publications finally start to show the excellent durability of iliac stenting in the daily practice. Park et al, described their long term (up to 10 years) experience in their total cohort of iliac patients (TASC type A-D lesions) and presented impressive primary patency rates of 87%, 83%, 61% and 49% at respectively 3, 5, 7 and 10 years after the index intervention. De Roeck et al. published their results after stenting of different types of iliac occlusions (TASC type B-D), and showed primary patency rates of 94%, 89% and 77% after respectively 1, 3 and 5 years follow up. They could also show that in their cohort of patients with complex aorto-iliac lesions, stent-failures can always be endovascularly rescued. They showed secondary patency rates of 100% after 1 year and 94% after both 3 and 5 years. Bosiers et al. concluded in their BRAVISSIMO trial primary patency rates at 12 months for the TASC A, B, C and D lesions of respectively 94.0%, 96.5%, 91.3% and 90.2%. Leville et al. questioned after the presentation of their outcome with stenting iliac occlusion (primary patency rate of 76% and secondary patency rate of 90% after 3 years), whether the endovascular treatment for iliac occlusive disease should be extended to Type C and D lesions. Leville came to this conclusion as they could not detect any significant differences in outcome for both primary and secondary patency rates stratifying for the TASC classifications. They summarized the treatment of iliac artery occlusion can be accomplished via endovascular means with little morbidity and acceptable patency rates. The COBEST trial demonstrates that covered and bare-metal stents produce similar and acceptable results for TASC B lesions. However, covered stents perform better for TASC C and D lesions than bare stents in longer-term patency and clinical outcome. Sabri et al. concluded that the use of covered balloon-expandable kissing stents for atherosclerotic aortic bifurcation occlusive disease provides superior patency at 2 years as compared with bare metal balloon-expandable stents. Bosiers et al. experienced that the implantation of the Advanta V12 PTFE-covered stent for iliac occlusive disease shows to be safe and feasible with excellent clinical results at 1 year in the investigated patient cohort. The TASC stratification is an important tool in allowing us to assess the extent of lesion morphology, but extensive lesions do not preclude successful endovascular treatment. They continued that the fate of the limb is dictated by the infrainguinal disease that is often present in patients with complex iliac occlusions and therefore believe that endovascular attempts should be exhausted before attempting open surgical repair of iliac occlusions because of the decreased perioperative morbidity and good mid-term durability.
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Inclusion and exclusion criteria
Inclusion Criteria
General Inclusion criteria
Angiographic Inclusion Criteria
The target lesion is either a modified TASC-II class A, B, C or D lesion with one of the listed specifications:
Type A lesions
Type B lesions
Type C lesions
Type D lesions
The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
There is angiographic evidence of a patent Common an Deep Femoral Artery
Exclusion Criteria
PTA is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter)
Presence of an aneurysm immediately adjacent to the site of stent implantation
Stenosis distal to the site of stent implantation
Lesions in or adjacent to essential collateral(s)
Lesions in locations subject to external compression
Heavily calcified lesions resistant to PTA
Patients with diffuse distal disease resulting in poor stent outflow
Patients with a history of coagulation disorders
Patients with aspirin allergy or bleeding complications and patients unable or unwilling to tolerate anticoagulant/antiplatelet therapy and/or non-responders to anticoagulant/antiplatelet therapy
Fresh thrombus formation
Patients with known hypersensitivity to the stent material (L605) and/or PTFE
The target lesion is either a modified TASC-II class B or D lesion with aortic or common femoral lesion involvement:
Type B lesions
Type C lesions
Type D lesions
Previously implanted stent(s) at the same lesion site
Reference segment diameter is not suitable for the available stent design
Untreatable lesion located at the distal outflow arteries
Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure
Patients refusing treatment
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 a history of prior life-threatening contrast medium reaction
Patients with uncorrected bleeding disorders
Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
Life expectancy of less than twelve months
Any planned surgical intervention/procedure within 30 days of the study procedure
Any patient considered to be hemodynamically unstable at onset of procedure
Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period
Primary purpose
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Interventional model
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70 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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