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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 (PRISTINE)

Primary Purpose

Critical Lower Limb Ischemia, Peripheral Artery Disease

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
SELUTION Sirolimus DCB
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Lower Limb Ischemia focused on measuring Drug-eluting balloon, Sirolimus

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Age of subject is > 21 years old.
  2. Patient has critical limb ischemia, presenting a score from 4 to 6 following Rutherford classification
  3. Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
  4. Patient is willing to comply with specified follow-up evaluations at the specified times
  5. Patient has a projected life expectancy of at least 12 months and has not suffered an MI within past 30 days
  6. Prior to enrolment, the guidewire has crossed the target lesion

Angiographic Inclusion Criteria

  1. De novo and post-PTA re-stenotic lesions located in the SFA, popliteal and/or tibial arteries suitable for endovascular therapy
  2. The target lesion is located within the SFA, popliteal and/or tibial and infra-malleolar arteries
  3. The length of the target lesion is > 50mm and considered as TASC C or D lesion according to the TASC II classification.
  4. The target lesion has angiographic evidence of stenosis > 50% or occlusion, which has been passed with standard guidewire manipulation and pre-dilated to <30% residual stenosis using any combination of POBA, high pressure POBA, scoring balloon, or rotablator.
  5. Target vessel diameter visually estimated is >1.5mm and <7 mm below the groin to the foot
  6. Lesions in the treated segment may be continuous or may have gaps present between stenoses and occlusions
  7. The target lesion has both patent inflow and at least one patent outflow tract extending to below the ankle. If required, the vessels of the ankle and foot should be treated with pre-dilatation and deployment of an appropriated sized balloon (i.e. smaller sized POBA or Selution study device) to establish distal flow reconstitution and adequate foot blush prior to treatment of the target tibial lesion.
  8. Inflow iliac and common femoral artery lesions can be treated during the same procedure using standard angioplasty and/or approved device. These inflow lesions must be treated first prior to consideration of treatment of the BTK lesions. The patient can be enrolled if the inflow lesions are treated with good angiographic results (must have < 30% residual stenosis and no evidence of embolization)
  9. There is angiographic evidence of at least one vessel-runoff through the ankle and into the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention

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%

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Angioplasty with SELUTION Sirolimus DCB

Arm Description

Subjects with infra-inguinal occlusive lesions will be treated with SELUTION Sirolimus DCB

Outcomes

Primary Outcome Measures

Freedom from Major Adverse Events
Composite of freedom from device- and procedure-related mortality
Freedom from clinically driven target lesion revascularization
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

Primary patency
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
Technical Success
Ability to cross and dilate the lesions and achieve residual angiographic stenos no greater than 30%
Freedom from clinically-drive target lesion revascularization
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
Improvement of Rutherford classification at all follow-up time points of one class or more as compared to the pre-procedure Rutherford classification
Wound healing
Closure of primary wound by more than 70%
Freedom from major target limb amputation
Freedom from Serious Adverse Events

Full Information

First Posted
August 26, 2020
Last Updated
May 24, 2022
Sponsor
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04534257
Brief Title
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
Acronym
PRISTINE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
May 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Lower Limb Ischemia, Peripheral Artery Disease
Keywords
Drug-eluting balloon, Sirolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Angioplasty with SELUTION Sirolimus DCB
Arm Type
Experimental
Arm Description
Subjects with infra-inguinal occlusive lesions will be treated with SELUTION Sirolimus DCB
Intervention Type
Device
Intervention Name(s)
SELUTION Sirolimus DCB
Intervention Description
Suitable lesions will be treated with SELUTION Sirolimus DCB
Primary Outcome Measure Information:
Title
Freedom from Major Adverse Events
Description
Composite of freedom from device- and procedure-related mortality
Time Frame
30 days post-index procedure
Title
Freedom from clinically driven target lesion revascularization
Description
Any re-intervention performed for more than 50% diameter stenosis at target lesion after documentation of recurrent or unresolved and continuing clinical symptoms
Time Frame
6 months post-index procedure
Secondary Outcome Measure Information:
Title
Primary patency
Description
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
Time Frame
6 and 12 months post-index procedure
Title
Technical Success
Description
Ability to cross and dilate the lesions and achieve residual angiographic stenos no greater than 30%
Time Frame
Immediately post-op
Title
Freedom from clinically-drive target lesion revascularization
Description
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
Time Frame
12 month post-index procedure
Title
Clinical success at follow-up
Description
Improvement of Rutherford classification at all follow-up time points of one class or more as compared to the pre-procedure Rutherford classification
Time Frame
6 and 12 months post index procedure
Title
Wound healing
Description
Closure of primary wound by more than 70%
Time Frame
6 months post-index procedure
Title
Freedom from major target limb amputation
Time Frame
6 and 12 months post-index procedure
Title
Freedom from Serious Adverse Events
Time Frame
1 year post-index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Age of subject is > 21 years old. Patient has critical limb ischemia, presenting a score from 4 to 6 following Rutherford classification Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study Patient is willing to comply with specified follow-up evaluations at the specified times Patient has a projected life expectancy of at least 12 months and has not suffered an MI within past 30 days Prior to enrolment, the guidewire has crossed the target lesion Angiographic Inclusion Criteria De novo and post-PTA re-stenotic lesions located in the SFA, popliteal and/or tibial arteries suitable for endovascular therapy The target lesion is located within the SFA, popliteal and/or tibial and infra-malleolar arteries The length of the target lesion is > 50mm 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 has been passed with standard guidewire manipulation and pre-dilated to <30% residual stenosis using any combination of POBA, high pressure POBA, scoring balloon, or rotablator. Target vessel diameter visually estimated is >1.5mm and <7 mm below the groin to the foot Lesions in the treated segment may be continuous or may have gaps present between stenoses and occlusions The target lesion has both patent inflow and at least one patent outflow tract extending to below the ankle. If required, the vessels of the ankle and foot should be treated with pre-dilatation and deployment of an appropriated sized balloon (i.e. smaller sized POBA or Selution study device) to establish distal flow reconstitution and adequate foot blush prior to treatment of the target tibial lesion. Inflow iliac and common femoral artery lesions can be treated during the same procedure using standard angioplasty and/or approved device. These inflow lesions must be treated first prior to consideration of treatment of the BTK lesions. The patient can be enrolled if the inflow lesions are treated with good angiographic results (must have < 30% residual stenosis and no evidence of embolization) There is angiographic evidence of at least one vessel-runoff through the ankle and into the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention Exclusion Criteria: Patient refusing treatment Patient is permanently wheel-chair bound or bedridden Presence of a stent in the target lesion that was placed during a previous procedure The intervention is being performed in preparation for a planned major amputation. Untreated flow-limiting inflow lesions Any previous surgery in the target vessel (including prior ipsilateral crural bypass) Previous bypass surgery in the same limb Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated Perforation at the angioplasty site evidenced by extravasation of contrast medium Untreatable lesion located at the distal outflow arteries Patients with uncorrected bleeding disorder Aneurysm located at the level of the SFA/popliteal artery Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis) Any condition which prevents patient from complying with the study protocol or if patient has a life expectancy of <1 year. Major distal amputation (above the transmetatarsal) in the study limb or non-study limb Septicaemia or bacteraemia Patient has undrained pus or spreading wet gangrene in the foot that is not controlled at the time of revascularization procedure Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb) episode of acute limb ischaemia within the previous 1 month Use of, 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 The patient is currently breast-feeding, pregnant or intends to become pregnant. 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. 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. 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 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 Patients with lesion to be treated with residual stenosis after POBA of >30%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tjun Yip Tang
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tze Tec Chong
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169856
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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