Peripheral Arterial Disease Clinical Trial
Official title:
Endovascular Treatment of Peripheral Artery Disease.
NCT number | NCT03414515 |
Other study ID # | BM-PAD-02 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2, 2018 |
Est. completion date | December 1, 2021 |
Verified date | December 2021 |
Source | Duomed |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635 or Qualimed Pontos-pp) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 1, 2021 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patient must sign the informed consent form prior to the index-procedure. 2. Patient is older than 18 years. 3. Patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime. 4. Patient suffers from mild to intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4-5). 5. Target lesion is an occlusion or diameter stenosis is =50% by visual estimate. 6. Target lesion is located in the common and external iliac artery, in the common and superficial femoral artery, popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery). Exclusion Criteria: 1. Patients with Rutherford 0 and 6. 2. Patient is pregnant. 3. Patients with estimated Glomerular filtration rate (eGFR) < 30 mL/min/1.73m2. 4. Patient has an acute thrombus or aneurysm in the target arteries. 5. Patient has a life expectancy of <12 months. 6. Patient has a target lesion that cannot be crossed with a guidewire. 7. Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability. 8. Patient has scheduled elective non-vascular procedures within 3 months after index-procedure. Vascular procedures are allowed within 3 months after the index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted. 9. Contraindication for anti-thrombotic therapy (coagulopathy, …). 10. Patient has a known intolerance to anti-thrombotic medication or contrast agents. |
Country | Name | City | State |
---|---|---|---|
Belgium | Heilig Hart Ziekenhuis | Mol | Antwerp |
Lead Sponsor | Collaborator |
---|---|
Duomed |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Binary restenosis | Binary restenosis defined as = 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio >2.4) | at 12 months follow-up | |
Secondary | Device-related complications | Registration of peri- and early/late postoperative complications | up to 12 months follow-up | |
Secondary | Immediate procedural outcome | The combination of technical success defined as a successful access and deployment of the device and achievement of a final residual diameter stenosis of <30% of the treated target lesion on the procedural completion angiography and procedural success defined as a combination of technical success and absence of procedural complications. | during index-procedure | |
Secondary | Clinical outcome | Rutherford classification | at baseline | |
Secondary | Clinical outcome | Rutherford classification | at 6 weeks follow-up | |
Secondary | Clinical outcome | Rutherford classification | at 12 months follow-up | |
Secondary | Primary sustained clinical improvement | defined as sustained upward shift of = 1 category on Rutherford classification without the need for repeated TLR in surviving patients. | at 12 months follow-up | |
Secondary | Secondary sustained clinical improvement | defined as sustained upward shift of = 1 category on Rutherford classification including the need for repeated TLR in surviving patients. | at 12 months follow-up | |
Secondary | Target lesion revascularization (TLR) | defined as an endovascular or surgical treatment due to a problem arising from the lesion (+1cm proximally and distally to include edge phenomena). | up to 12 months follow-up | |
Secondary | Mortality | Procedure-related and all-cause mortality. | up to 12 months follow-up | |
Secondary | Amputation | minor amputation defined as below the ankle and major defined as above the ankle. | up to 12 months follow-up |
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