Endovascular Treatment of Peripheral Artery Disease (PAD)

Duomed200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Peripheral Arterial Disease Iliac Artery Disease Femoropopliteal Occlusive Disease Below-the-knee Obstruction

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Binary restenosis

Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio \>2.4)

Time frame: at 12 months follow-up

Secondary Outcomes

Device-related complications

Registration of peri- and early/late postoperative complications

Time frame: up to 12 months follow-up

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.

Time frame: during index-procedure

Clinical outcome

Rutherford classification

Time frame: at baseline

Clinical outcome

Rutherford classification

Time frame: at 6 weeks follow-up

Clinical outcome

Rutherford classification

Time frame: at 12 months follow-up

Primary sustained clinical improvement

defined as sustained upward shift of ≥ 1 category on Rutherford classification without the need for repeated TLR in surviving patients.

Time frame: at 12 months follow-up

Secondary sustained clinical improvement

defined as sustained upward shift of ≥ 1 category on Rutherford classification including the need for repeated TLR in surviving patients.

Time frame: at 12 months follow-up

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).

Time frame: up to 12 months follow-up

Mortality

Procedure-related and all-cause mortality.

Time frame: up to 12 months follow-up

Amputation

minor amputation defined as below the ankle and major defined as above the ankle.

Time frame: up to 12 months follow-up

Data from ClinicalTrials.gov

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Endovascular Treatment of Peripheral Artery Disease (PAD)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes