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Singapore INfra-Genicular Angioplasty With PAclitaxel-eluting Balloon for Critical Limb Ischaemia (SINGA-PACLI) Trial (SINGA-PACLI)

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ClinicalTrials.gov Identifier: NCT02129634
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
Tan Tock Seng Hospital
Duke-NUS Graduate Medical School
Singapore Clinical Research Institute
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:

Background

- In patients with critical limb ischaemia (CLI), the infragenicular arteries are often involved. Without revascularisation, amputation often is imperative. There is a high technical success rate of endovascular revascularisation of infragenicular arteries with percutaneous transluminal angioplasty (PTA), but mid- and long-term results are disappointing as restenosis frequently occurs. Drug-eluting balloon (DEB) PTA has been shown to improve patency rates after PTA of coronary arteries.

Aim

  • To study the results of DEB-PTA compared to conventional balloon CB-PTA for the treatment of infragenicular lesions in patients with CLI.
  • To evaluate cost-effectiveness of DEB-PTA versus CB-PTA in patients with critical limb ischemia (CLI) by quantifying the incremental cost-effectiveness ratio (ICER).

Hypothesis

  • DEB PTA results in improved patency rates compared to CB-PTA for treatment of infragenicular arterial lesions in patients with CLI.
  • DEB-PTA is a cost-effective strategy in patients with CLI compared with CB-PTA.

Methodology Multi-center, prospective, randomised parallel-group trial. Patients are eligible for enrolment if they have CLI and at least one infragenicular lesion with a maximal total lesion length of 20cm. Randomisation will be performed on a 1:1 ratio to either DEB-PTA or CB-PTA. Patients will be assessed prior and directly after the intervention, at 3, 6 and 12 months by Rutherford classification, ankle-brachial index, toe pressure and adverse events. Duplex will be performed at 3 months. Angiography will be performed before and directly after PTA and at 6 months. Primary end-point will be primary patency of the treated lesions at 6 months on angiography (defined as <50% stenosis, without re-intervention in the interim). Secondary end-points are limb salvage at 3, 6 and 12 months, primary patency of the treated lesion on Duplex at 3 months (defined as patency of the treated artery with peak systolic velocity (PSV) ≤2.0 m/sec), Rutherford classification, minor and major amputation, infrapopliteal endovascular re-intervention, patency of treated femoropopliteal sites (if applicable), infrapopliteal surgical bypass, peri-procedural complications and death at 3, 6 and 12 months.

A cost-effectiveness analysis (CEA) from a societal perspective will be performed in parallel with the randomized clinical trial with a 12-month time horizon.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: CB-PTA Device: DEB-PTA Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Singapore INfra-Genicular Angioplasty With PAclitaxel-eluting Balloon for Critical Limb Ischaemia (SINGA-PACLI) Trial
Actual Study Start Date : December 27, 2013
Actual Primary Completion Date : October 6, 2018
Actual Study Completion Date : October 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Active Comparator: CB-PTA arm
After successful crossing of the trial lesion, a conventional angioplasty balloon with a diameter matching the trial vessel is advanced over the guidewire and is inflated at the trial lesion site, according to the normal practice of the operator. Comparisons of pre- and post-angioplasty percentage stenosis will be made in the same angiographic projection(s).
Device: CB-PTA
Other Name: Conventional Balloon-Percutaneous Transluminal Angioplasty

Experimental: DEB-PTA arm
After successful crossing of the trial lesion, angioplasty with a conventional angioplasty balloon is performed before DEB-PTA. This is because the paclitaxel coating may be scrapped off the balloon if the DEB is used to cross the trial lesion. A conventional angioplasty balloon with a diameter matching the trial vessel is advanced over the guidewire and is inflated at the trial lesion site, according to the normal practice of the operator. A DEB with a diameter matching the trial vessel and lesion length is then advanced over the 0.018 inch guidewire and inflated at the trial lesion site for 60 seconds. If the lesion length is longer than the length of the balloon, a second inflation with another DEB will be required. The maximal total lesion length of the treated lesions will not exceed 20cm. Comparisons of pre- and post-angioplasty percentage stenosis will be made in the same angiographic projection(s).
Device: CB-PTA
Other Name: Conventional Balloon-Percutaneous Transluminal Angioplasty

Device: DEB-PTA
Other Name: Paclitaxel-eluting Balloon-Percutaneous Transluminal Angioplasty




Primary Outcome Measures :
  1. Primary patency of the treated (index) site at 6 months [ Time Frame: 6 months ]
    Primary patency is defined as less than or equal 50% loss of luminal diameter at the treated site on angiography without re-intervention in the interim.


Secondary Outcome Measures :
  1. Limb-salvage rate [ Time Frame: at 3, 6 and 12 months ]
    Limb-salvage rate of the trial leg at 3, 6 and 12 months.

  2. Primary patency of the treated (index) site [ Time Frame: at 3 months ]
    Primary patency on duplex sonography of the treated (index) site at 3 months

  3. Clinical categorisation of the treated ischemic leg [ Time Frame: at 3, 6 and 12 months ]
    Clinical categorisation of the treated ischemic leg by means of the Rutherford classification at 3, 6 and 12 months.

  4. Minor amputation [ Time Frame: at 3, 6 and 12 months ]
    Minor amputation of the trial leg at 3, 6 and 12 months.

  5. Infrapopliteal surgical bypass of the trial leg [ Time Frame: at 3, 6 and 12 months ]
    Infrapopliteal surgical bypass of the trial leg at 3, 6 and 12 months.

  6. Infrapopliteal endovascular re-intervention of the trial leg [ Time Frame: at 3, 6 and 12 months ]
    Infrapopliteal endovascular re-intervention of the trial leg at 3, 6 and 12 months

  7. Primary patency of treated femoropopliteal sites [ Time Frame: From the date of randomization until the date of end of primary patency of treated femoropopliteal sites (asscessed up to 12 months) ]
    Primary patency of treated femoropopliteal sites

  8. Peri-procedural complications [ Time Frame: (within 30 days) ]
    Peri-procedural (within 30 days) complications

  9. Death [ Time Frame: From the date of randomization until the date of death from any cause (asscessed up to 12 months) ]
    Death

  10. Incremental cost-effectiveness ratio (ICER) [ Time Frame: at 3 month, 6 month and 12 month ]
    Incremental cost-effectiveness ratio (ICER), i.e., the mean difference in costs divided by the mean difference in QALY



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Age > 21 years
  • If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study
  • Patient is willing and able to comply with the specified follow-up evaluation
  • Critical Limb Ischaemia, Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss)
  • Stenosis (>50% luminal loss) or occlusion of infra-genicular arteries (defined as: distal to the infra-popliteal artery), including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery
  • Infragenicular arterial lesions with length of <20cm
  • At least one crural (anterior tibial, posterior tibial or peroneal) artery with expected unobstructed runoff to ankle level after treatment
  • Successful guidewire crossing of the trial lesion

Exclusion Criteria:

  • Acute limb ischaemia
  • Subacute limb ischaemia which requires thrombolysis as first treatment modality
  • Previous major amputation of the affected limb (at or above the level of the ankle)
  • Concurrent iliac or femoropopliteal artery disease not suitable for endovascular or surgical revascularisation
  • Concurrent iliac or femoropopliteal artery occlusion of >10cm, even if suitable for surgical or endovascular revascularization
  • Patients without (expected) distal runoff to the index site
  • Revascularization involving the same site within 30 days prior to the index procedure or planned revascularization of the same limb within 30 days of the index procedure
  • Previous implanted stent at the index site
  • Life expectancy of less than 6 months
  • Factors making clinical follow-up very difficult or impossible
  • Known allergy to paclitaxel
  • Known allergy to contrast media
  • Patients on Warfarin or any other anti-coagulants
  • Known allergy to anti-platelet drugs (Aspirin/ Clopidogrel) (or) unable to tolerate dual anti-platelet drugs therapy
  • Active history of gastritis and other bleeding tendencies precluding use of dual anti-platelet therapy
  • Known heparin induced thrombocytopenia (HIT type 2)
  • Patient unable or unwilling to tolerate contrast media
  • eGFR less than 50 ml/min/1.73m2 unless patient is on dialysis.
  • If the patient has significant heart disease and Left Ventricular Ejection Fraction Percentage (LVEF%) is less than 35 %.
  • Either PT/PTT of >1.5 times the median of normal that cannot be corrected for the time of the procedure (or ) INR >1.6 that cannot be corrected for the time of the procedure
  • Thrombocytopenia of platelet count <50,000 /µL (50 X 109/L) which cannot be corrected for the time of the procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129634


Locations
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Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Sponsors and Collaborators
Singapore General Hospital
Tan Tock Seng Hospital
Duke-NUS Graduate Medical School
Singapore Clinical Research Institute
Investigators
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Principal Investigator: Bien Soo Tan, MBBS, FRCR, FAMS Singapore General Hospital

Additional Information:
Publications:

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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT02129634     History of Changes
Other Study ID Numbers: SINGA-PACLI_01
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

Keywords provided by Singapore General Hospital:
Percutaneous Transluminal Angioplasty
Limb-salvage
Randomized Controlled Trial
Paclitaxel

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Ischemia
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action