Endovascular Treatment of Peripheral Artery Disease

Peripheral Arterial Disease Clinical Trial

— PAD  

Official title:

Endovascular Treatment of Peripheral Artery Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03346577
• Other study ID #: BM-PAD-01
• Status: Terminated
• Start date: May 2, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: January 2021
• Source: be Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635) 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• 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 intermittent claudication (Rutherford 2-3) or critical limb ischemia (Rutherford 4-5).

5. Target lesion is an occlusion or diameter stenosis is =70% 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, 1 and 6.

2. Patient is pregnant.

3. Patients with serum creatinine >2.0 mg/dL or renal dialysis.

4. Patient has an acute thrombus or aneurysm in the target arteries.

5. Patient has a life expectancy of <12 months.

6. Patient with bypass that involves the target arteries.

7. Patient has a target lesion that cannot be crossed with a guidewire.

8. Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.

9. 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.

10. Contraindication for anti-thrombotic therapy (coagulopathy, …).

11. Patient has a known intolerance to anti-thrombotic medication or contrast agents.

Related Conditions & MeSH terms

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

Intervention

Device:
• stent or balloon
Endovascular treatment with stent or balloon according to current practice

Locations

Country	Name	City	State
Belgium	Mariaziekenhuis Noord-Limburg	Overpelt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
be Medical

Country where clinical trial is conducted

Belgium, 

Outcome

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.	up to 12 months follow-up
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
Secondary	Stent fracture	Only if restenosis occurs, stent fracture will be examined (when Optimed Sinus Superflex 635 stent is used).	up to 12 months follow-up