Critical Limb IschemiaPINNACLENCT04534192
Investigating the Safety and Efficacy of the Treatment With the Non-compliant Jade Balloon in TASC C and D Athero-occlusive Infra-inguinal Disease in Patients With Chronic Limb Threatening Limb Ischemia From SingaporE
A study testing JADE Balloon in people with Critical Limb Ischemia and Peripheral Artery Disease, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The objective of this clinical study is to evaluate the 6-month safety and performance outcome of the non-compliant high pressure JADE balloon for the treatment of infrainguinal stenotic occlusive or stenotic TASC C \& D lesions in patients with chronic limb threatening ischemia. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Critical Limb Ischemia, Peripheral Artery Disease
- What is being tested?
- JADE Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Aug 2020to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of subject is > 40 years old. Patient covered by MediShield insurance as provided by Singapore government.
- Patient has critical limb ischemia, presenting a score from 4 to 6 following the Rutherford classification
- Patients must agree to return for all required post-index procedure follow-up visits.
- 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 and has not suffered a myocardial infarction within past 30 days
- Angiographic Inclusion Criteria:
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- De novo and post-PTA re-stenotic lesions located in the superficial femoral, popliteal and tibial arteries suitable for endovascular therapy
- The target lesion is located within the native SFA/popliteal/tibial artery
- The length of the target lesion(s) is > 100mm 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 no other adjunctive devices have been used to prepare the lesion (example scoring balloon, rotablator, atherectomy device)
- Target vessel diameter visually estimated is >1.5mm and < 6.5mm below the groin
- Prior to enrolment, the guidewire has crossed the target lesion
- Lesions in the treated segment may be continuous or may have gaps present between stenoses and occlusions
- Inflow iliac, common femoral artery lesions can be treated during the same procedure using standard angioplasty and/or approved device/open surgery. These inflow lesions must be treated first prior to consideration of treatment of the distal lying lesions. The patient can be enrolled if the inflow lesions are treated with good 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
Who cannot join
- Patient is permanently wheel-chair bound or bedridden
- Presence of a stent in the target lesion(s) that was placed during a previous procedure
- The intervention is being performed in preparation for a planned 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
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- Patients with a history of Myocardial Infarction (MI), thrombolysis or angina within 30 days prior-index procedure.
- Patients with a history of major disabling stroke within 3 months prior index procedure.
- Patients with any type of previous or planned surgical or interventional procedure within 15 days prior- and/or within 30 days post-index procedure.
- Untreatable lesion located at the distal outflow arteries
- Patients with uncorrected bleeding disorders
- 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 <1yr.
- Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
- Patients with a presence or history of severe renal failure (Glomerular Filtration Rate (GFR) ≤ 30 ml/min) and is not dialysis dependent.
- 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 thrombectomy, cutting balloon, lithotripsy, atherectomy or laser devices during procedure
- Any patient considered to be hemodynamically unstable at onset of procedure
- Patients with a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or other anticoagulant/anti-platelet therapies or sensitivity to contrast media that cannot be adequately premedicated.
- 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 Rifampin) within 90 days following the procedure.
- 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
- Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the Investigational Device.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169856
Charyl Yap, 6576 7986, Charyl.yap.j.q@sgh.com.sg
Tjun Yip Tang
About this study
Official title: Physician Initiated, Prospective, Non-randomized Single-centre, Single-arm Trial, Investigating the Safety and Efficacy of the Treatment With the Non-compliant Jade Balloon in TASC C and D Athero-occlusive Infra-inguinal Disease in Patients With Chronic Limb Threatening Limb Ischemia From SingaporE (PINNACLE)
The objective of this clinical study is to evaluate the 6-month safety and performance outcome of the non-compliant high pressure JADE balloon for the treatment of infrainguinal stenotic occlusive or stenotic TASC C \& D lesions in patients with chronic limb threatening ischemia.
Read the detailed description
Pulsatile straight line blood flow to the foot is required to aid wound healing in the setting of chronic limb threatening ischaemia (CLTI). Patients with CLTI usually present with infra-popliteal arterial occlusions and endovascular therapies to restore blood flow are often preferred considering their inherently less invasive nature and because of multiple patient background comorbidities or absence of a suitable vein conduit in these patients. Below The Knee (BTK) plain balloon angioplasty (POBA) remains the only viable "standard of care" in the management of long "Real World" BTK Lesions. However tibial angioplasty is plagued by high rate of re-occlusion/stenosis because of barotrauma caused by the intra-arterial ballooning and subsequent development of neointimal hyperplasia. Devices coated with paclitaxel have been used successfully to limit restenosis by inhibiting the biologic pathway that leads to intimal hyperplasia. However, a recent formal systematic review and study-level meta-analysis of randomized controlled trials investigating treatment of the infra-popliteal arteries with paclitaxel-coated balloons compared with conventional balloon angioplasty for critical limb ischemia (CLI) was recently published showing amputation-free survival was significantly worse in use of paclitaxel coated balloons compared to plain angioplasty. Furthermore current poor patency seen in BTK angioplasty is likely contributed in part by small vessel size and poor luminal gain after standard semi-compliant POBA. Vessel Preparation and Optimising POBA with High Pressure, Non-Compliant balloons may help achieve Luminal Gain for rapid and sustained flow for wound healing. The objective of this clinical study is to evaluate the 6-month safety and performance outcome of the non-compliant high pressure JADE balloon for the treatment of infrainguinal stenotic occlusive or stenotic TASC C \& D lesions in patients with chronic limb threatening ischemia.
- Conditions
- Critical Limb Ischemia, Peripheral Artery Disease
- Being tested
- JADE Balloon
- Keywords
- non-compliant high pressure balloon, JADE
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JADE BalloonDevice
Suitable TASC C and D lesions will be treated with non-compliant high pressure JADE balloon.
| Study group | Role | What they receive |
|---|---|---|
| JADE balloon | Experimental | Non-compliant high pressure JADE balloon for the treatment of infrainguinal stenotic occlusive or stenotic TASC C \& D lesions in patients with chronic limb threatening ischemia. Receives: Device: JADE Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Major Adverse Events
A composite of freedom from device- and procedure-related mortality through 30 days
Measured: 30 days post-index procedure
Performance Primary Endpoint
Freedom from clinically driven target lesion revascularization (TLR) within 6 months post-index procedure. (Clinically driven TLR is defined as any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent or unresolved and continuing clinical symptoms of the patient.)
Measured: 6 months post-index procedure
Secondary outcomes (8)
Primary patency rate
defined as absence of a hemodynamically significant stenosis on Duplex ultrasound (systolic velocity ratio no greater than 2.5) at the target lesion and without TLR within the time of procedure and the given follow-up. Note: Any patient where DUS is not analysable at index and/or at follow-up, where there is documented significant progression of disease above the target lesion, or who undergo a major amputation prior to the time of follow-up will be excluded from the calculation of this endpoint.
Measured: 6- and 12-month post-index procedure
Technical success
defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%
Measured: Immediately post-op
Freedom from clinically-driven TLR
defined as a 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 the respective time points
Measured: 12-month post-index procedure
Clinical success at follow-up
defined as an improvement of Rutherford classification at all follow- up time points of one class or more as compared to the pre-procedure Rutherford classification
Measured: 6 and 12 months post index procedure
Wound healing
closure of primary wound by more than 70%
Measured: 6 months post-index procedure
Freedom from major target limb amputation (above ankle)
Measured: 6 months and 12 months post-index procedure
Improvements in walking
Comparison of the scores on the Walking Impairment Questionnaire (WIQ) between baseline and follow-ups.
Measured: 3, 6 and 12 months post-index procedure.
Freedom from serious adverse events
as defined per ISO 14155:2011
Measured: 3, 6 and 12 months post-index procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Aug 2020
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized, single arm
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Sponsor
- Investigators
- Tjun Yip Tang, MD, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534192
- Sponsor's protocol ID
- 2020/2425
- Acronym
- PINNACLE
- Status last verified
- Oct 2020
- First submitted
- 26 Aug 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Initiated, Prospective, Non-randomized Single-centre, Single-arm Trial, Investigating the Safety and Efficacy of the Treatment With the Non-compliant Jade Balloon in TASC C and D Athero-occlusive Infra-inguinal Disease in Patients With Chronic Limb Threatening Limb Ischemia From SingaporE (PINNACLE)
- ClinicalTrials.gov ID
- NCT04534192
- Acronym / sponsor ID
- PINNACLE / 2020/2425
- Conditions
- Critical Limb Ischemia, Peripheral Artery Disease
- Keywords
- non-compliant high pressure balloon, JADE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to evaluate the 6-month safety and performance outcome of the non-compliant high pressure JADE balloon for the treatment of infrainguinal stenotic occlusive or stenotic TASC C \& D lesions in patients with chronic limb threatening ischemia.
Detailed description
Pulsatile straight line blood flow to the foot is required to aid wound healing in the setting of chronic limb threatening ischaemia (CLTI). Patients with CLTI usually present with infra-popliteal arterial occlusions and endovascular therapies to restore blood flow are often preferred considering their inherently less invasive nature and because of multiple patient background comorbidities or absence of a suitable vein conduit in these patients. Below The Knee (BTK) plain balloon angioplasty (POBA) remains the only viable "standard of care" in the management of long "Real World" BTK Lesions. However tibial angioplasty is plagued by high rate of re-occlusion/stenosis because of barotrauma caused by the intra-arterial ballooning and subsequent development of neointimal hyperplasia. Devices coated with paclitaxel have been used successfully to limit restenosis by inhibiting the biologic pathway that leads to intimal hyperplasia. However, a recent formal systematic review and study-level meta-analysis of randomized controlled trials investigating treatment of the infra-popliteal arteries with paclitaxel-coated balloons compared with conventional balloon angioplasty for critical limb ischemia (CLI) was recently published showing amputation-free survival was significantly worse in use of paclitaxel coated balloons compared to plain angioplasty. Furthermore current poor patency seen in BTK angioplasty is likely contributed in part by small vessel size and poor luminal gain after standard semi-compliant POBA. Vessel Preparation and Optimising POBA with High Pressure, Non-Compliant balloons may help achieve Luminal Gain for rapid and sustained flow for wound healing. The objective of this clinical study is to evaluate the 6-month safety and performance outcome of the non-compliant high pressure JADE balloon for the treatment of infrainguinal stenotic occlusive or stenotic TASC C \& D lesions in patients with chronic limb threatening ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized, single arm
| Arm | Type | Receives |
|---|---|---|
| JADE balloon | Experimental | Device: JADE BalloonNon-compliant high pressure JADE balloon for the treatment of infrainguinal stenotic occlusive or stenotic TASC C \& D lesions in patients with chronic limb threatening ischemia. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age of subject is > 40 years old. Patient covered by MediShield insurance as provided by Singapore government.
- Patient has critical limb ischemia, presenting a score from 4 to 6 following the Rutherford classification
- Patients must agree to return for all required post-index procedure follow-up visits.
- 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 and has not suffered a myocardial infarction within past 30 days
Key exclusion criteria (25 listed)
- Patient is permanently wheel-chair bound or bedridden
- Presence of a stent in the target lesion(s) that was placed during a previous procedure
- The intervention is being performed in preparation for a planned amputation.
- Untreated flow-limiting inflow lesions
- Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JADE BalloonSuitable TASC C and D lesions will be treated with non-compliant high pressure JADE balloon. | Device | JADE balloon |
Primary outcome
Freedom from Major Adverse Events
Time frame: 30 days post-index procedure
A composite of freedom from device- and procedure-related mortality through 30 days
Performance Primary Endpoint
Time frame: 6 months post-index procedure
Freedom from clinically driven target lesion revascularization (TLR) within 6 months post-index procedure. (Clinically driven TLR is defined as any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent or unresolved and continuing clinical symptoms of the patient.)
8 secondary outcomes
Primary patency rate
Time frame: 6- and 12-month post-index procedure
Technical success
Time frame: Immediately post-op
Freedom from clinically-driven TLR
Time frame: 12-month post-index procedure
Clinical success at follow-up
Time frame: 6 and 12 months post index procedure
Wound healing
Time frame: 6 months post-index procedure
Freedom from major target limb amputation (above ankle)
Time frame: 6 months and 12 months post-index procedure
Improvements in walking
Time frame: 3, 6 and 12 months post-index procedure.
Freedom from serious adverse events
Time frame: 3, 6 and 12 months post-index procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tjun Yip Tang, MD principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JADE Balloon in people with Critical Limb Ischemia and Peripheral Artery Disease, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charyl Yap, BSc (65767986, Charyl.yap.j.q@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Major Adverse Events (time frame: 30 days post-index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.