Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore

Not Applicable

• Conditions: Peripheral Artery Disease; Critical Lower Limb Ischemia
• Interventions: Device: SELUTION Sirolimus DCB

• Registration Number: NCT04534257
• Lead Sponsor: Singapore General Hospital

Brief Summary

Extensive arterial occlusion significantly reduces arterial perfusion, and may eventually lead to Critical Limb Ischemia (CLI). The pathology gives rise to symptoms such as ischemic pain, slow healing wounds at lower extremity and gangrene. It places patients with multi-segment occlusion at high risks of amputations and mortality. The treatment methods for such long occlusive lesions are limited. Traditionally, the standard of care would be surgical revascularization. This is because lesion length have been identified in several studies as an independent risk factor for the development of restenosis after angioplasty and/or stenting. However, thanks to recent advances in endovascular techniques, such as the utilization of subintimal technique for crossing long segment occlusions, it is now possible to employ endovascular techniques for suitable patients.The re-establishment of an in-line flow, even if only temporary, can allow tissue healing, which is vital in achieving limb salvage. In addition, the use of Drug Coated Balloons (DCB) can potentially reduce restenosis rate, as Sirolimus have an anti-proliferative effect.

To date, there are few studies that have evaluated the performance of DCB in lesions that are longer than 10cm. The investigators hope to evaluate the performance of the Selution DCB when used in treatment of such lesions

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-09-01
• Study Start: 2020-09-09
• Primary Completion: 2021-12-20
• Status Verified: 2022-05
• Study Completion: 2022-05-20
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patient refusing treatment
2. Patient is permanently wheel-chair bound or bedridden
3. Presence of a stent in the target lesion that was placed during a previous procedure
4. The intervention is being performed in preparation for a planned major amputation.
5. Untreated flow-limiting inflow lesions
6. Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
7. Previous bypass surgery in the same limb
8. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
9. Perforation at the angioplasty site evidenced by extravasation of contrast medium
10. Untreatable lesion located at the distal outflow arteries
11. Patients with uncorrected bleeding disorder
12. Aneurysm located at the level of the SFA/popliteal artery
13. Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
14. Any condition which prevents patient from complying with the study protocol or if patient has a life expectancy of <1 year.
15. Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
16. Septicaemia or bacteraemia
17. Patient has undrained pus or spreading wet gangrene in the foot that is not controlled at the time of revascularization procedure
18. Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb)
19. episode of acute limb ischaemia within the previous 1 month
20. Use of, atherectomy or laser devices during procedure
21. Any patient considered to be hemodynamically unstable at onset of procedure
22. Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
23. The patient is currently breast-feeding, pregnant or intends to become pregnant.
24. Subject receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.) The patient should also not receive inhibitors of CYP3A (such as Itraconazole, and Erythromycin), or inducers of CYP3A (such as Rifampycin) within 90 days following the procedure.
25. Subject has tested positive for Dengue, Covid19, Ebola, SARS, or MERS. If subject becomes infected during the course of the study, the resulting outcomes data will be recorded but will not be included the analysable results from the study.
26. Patient is participating in another research study of a device, medication, biologic or other agent within 30 days which could in the opinion of the investigator affect the results of this study
27. Any patient who has received a paclitaxel coated DCB within 30 days prior to the index procedure. If the patient receives a paclitaxel DCB in a peripheral vessel during the index procedure, that patients clinical outcomes shall not be included in calculation of the primary or secondary endpoints of the study
28. Patients with lesion to be treated with residual stenosis after POBA of >30%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Angioplasty with SELUTION Sirolimus DCB	SELUTION Sirolimus DCB	Subjects with infra-inguinal occlusive lesions will be treated with SELUTION Sirolimus DCB

Primary Outcome Measures

Name	Time	Method
Freedom from Major Adverse Events	30 days post-index procedure	Composite of freedom from device- and procedure-related mortality
Freedom from clinically driven target lesion revascularization	6 months post-index procedure	Any re-intervention performed for more than 50% diameter stenosis at target lesion after documentation of recurrent or unresolved and continuing clinical symptoms

Secondary Outcome Measures

Name	Time	Method
Freedom from Serious Adverse Events	1 year post-index procedure
Primary patency	6 and 12 months post-index procedure	Absence of hemodynamically significant stenosis on duplex ultrasound at target lesion and without target lesion revascularization between time of procedure and the given follow-up
Wound healing	6 months post-index procedure	Closure of primary wound by more than 70%
Freedom from major target limb amputation	6 and 12 months post-index procedure
Technical Success	Immediately post-op	Ability to cross and dilate the lesions and achieve residual angiographic stenos no greater than 30%
Freedom from clinically-drive target lesion revascularization	12 month post-index procedure	Repeat 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 respective time points
Clinical success at follow-up	6 and 12 months post index procedure	Improvement of Rutherford classification at all follow-up time points of one class or more as compared to the pre-procedure Rutherford classification

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore