Peripheral Arterial Disease
Conditions
Brief summary
Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.
Detailed description
The study will enroll consecutive eligible subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo and restenotic atherosclerotic lesions in femoral, popliteal and infrapopliteal arteries. The purpose of this prospective, multicenter, observational European Study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications of endovascular peripheral interventions for treatment of lesions in the femoral, popliteal and infrapopliteal arteries.
Interventions
None listed
Sponsors
Biotronik AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject ≥18 years old 2. Subject has provided written informed consent 3. Subject has Rutherford classification 2 to 6 4. Reference vessel diameter ≥2 and ≤7 mm 5. Target lesion(s) has stenosis \>70% by visual assessment 6. Multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-between the lesions will be considered one lesion. For Above the knee (ATK) group 7. Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau) 8. At least 1 below-knee artery patent to the ankle 9. Successful treatment of inflow iliac stenosis to the target lesion. Inflow lesion stenosis can be treated during the same procedure as per local standard of care. For Below the knee (BTK) group: 10. Target lesions involve arteries below the tibial plateau 11. Successful treatment of inflow vessel (from ipsilateral iliac to the target lesion) resulting in ≤30% residual stenosis with no evidence of embolization or significant complications.
Exclusion criteria
1. Subject has a single target lesion that involves both ATK and BTK segment. 2. Subject not suitable for receiving endovascular procedures of lower limb arteries 3. Prior planned major amputation in the target limb (above the ankle) 4. Subject with previous bypass surgery of target vessel. 5. History of any open surgical procedure within the past 30 days. 6. Planned vascular surgery procedure within the next 30 days after the ATK and/or BTK procedure on the target limb. Note: The inflow vessels can be treated on the day of the procedure 7. Subject under dialysis 8. Subject currently enrolled in another investigational device, biologic, or drug trial in which the primary endpoint has not yet been reached 9. Subject lacking capacity to provide informed consent 10. Subject under judicial protection, tutorship, or curatorship (for France only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success rate | Index Procedure | Combination of technical success and absence of procedural complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure technical success rate | Index Procedure | successful crossing and achievement of a final residual diameter stenosis of ≤30% of the treated target lesion on the procedural completion angiography |
| Rate of target lesion bailout stenting | Index Procedure | Stented target lesion |
| Stented length | Index Procedure | Stented length |
| Rate of PTA balloon related flow-limiting dissections | Index Procedure | PTA balloon related flow-limiting dissections |
| Rate of distal embolization | Index Procedure | Distal embolization |
| Rate of target vessel rupture | Index Procedure | Target vessel rupture |
| Rate of acute occlusion | Index Procedure | Acute occlusion |
| Primary crossing success rate | Index Procedure | Successfully placement of a guidewire into the distal true lumen with the primary crossing strategy |
| Rate of Serious Adverse Device Effects | Index Procedure | Serious Adverse Device Effects |
| Non-labor resource use | Index procedure until discharge | Devices use |
| Rate of target vessel perforation | Index Procedure | Target vessel perforation |
Countries
Austria, Belgium, France, Germany, Hungary, Italy, Spain, Switzerland
Outcome results
None listed