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Updated: May 10, 2026
Predicting Amputation using Local Circulating Mononuclear Progenitor Cells in Angioplasty-treated Patients with Critical Limb Ischemia
Published on: September 22, 2020
New approach to protected percutaneous transluminal angioplasty in the lower limbs
Thomas Zeller1, Andrej Schmidt, Aljoscha Rastan
1Department of Angiology, Universitaets-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany. thomas.zeller@universitaets-herzzentrum.de
Insights
The Proteus embolic capture balloon effectively captured embolic particles during lower limb interventions, demonstrating high procedural success and safety. It is a valuable tool for complex lesions where embolism risk is high.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- Embolism is a significant risk during lower limb interventions.
- Effective embolic protection devices are crucial for improving patient outcomes.
- The Proteus embolic capture balloon aims to mitigate embolic events.
Purpose of the Study:
- To assess the safety and efficacy of the Proteus embolic capture balloon.
- To evaluate the indications for using this device in lower limb interventions.
- To analyze the particle capture characteristics of the Proteus balloon.
Main Methods:
- Prospective, multicenter, single-arm study with 123 patients.
- Primary endpoint: freedom from death, amputation, and target vessel revascularization (TVR) at 30 days.
- Follow-up at 30 days and 12 months; histological analysis of captured particles.
Main Results:
- 95.9% freedom from death, amputation, and TVR at 30 days.
- High procedural (98.7%) and device (97.8%) success rates.
- 100% of balloons captured particles, with characteristics varying by lesion type (e.g., long, totally occluded, thrombotic).
Conclusions:
- Proteus demonstrated significant embolic particle capture ability.
- The device is effective in complex lesions with calcified or thrombotic material.
- Proteus is a valuable tool for preventing distal embolization during lower limb interventions.
Purpose:
To provide evidence for the safety and efficacy of the Proteus embolic capture balloon in lower limb interventions and to evaluate its indications for use.
Methods:
The study was designed as a prospective, multicenter, non-randomized, single arm study enrolling 123 patients (78 men; mean age 68 years). The primary endpoint was rate of freedom from death, amputation, and target vessel revascularization (TVR) at 30 days post procedure. Follow-up was performed at 30 days and at 12 months.
Results:
The freedom from death, amputation, and TVR rate was 95.9% (118/123). Procedure and device success rates were 98.7% (218/223) and 97.8% (156/158), respectively. TVR and death rates at 12 months were 18.8% and 4.1%, respectively. Histological analysis identified particles in 100% of the balloons. The median number of particles per subject was 339 (range 63-4361). Medians of particle size and total particle area were 0.8 (range 0.3-8.3) and 1.0 mm(2) (range 0.1-237) per balloon, respectively. Particles >1 mm were found in 37% (53/143) of the balloons analyzed. Higher mean number, length, and surface area of particles were found in long lesions (909±1057, 2.6±2.3 mm, and 18.2±44.2 mm(2), respectively; all p<0.0001 vs. short lesions). Additionally, longer particles were found in total occlusions (2.5±2.5 mm, p<0.0001), and a higher mean particle count was found in thrombotic lesions (1785±1821, p<0.05). De novo lesions had more thrombotic material than any other type of lesion.
Conclusion:
Proteus demonstrated good particle capture ability, making it a useful tool in situations where embolism is anticipated, such as complex lesions with calcified or thrombotic material and/or lesions with high plaque burden (i.e., long and totally occluded).
