Table 11.1.
IDEAL: Stages of surgical and endovascular innovation for chronic limb-threatening ischemia (CLTI)
| Stage | 1. Idea | 2a. Development | 2b. Exploration | 3. Assessment | 4. Long-term study |
|---|---|---|---|---|---|
|
| |||||
| Patients | Single digit, highly selected and homogeneous | Few; selected and homogeneous | Many; more heterogeneous | Many; expanded but well-defined indications | All eligible |
| Vascular specialists | Very few; innovators | Few; innovators and early adopters | Many; innovators, early adopters, early majority | Many; early majority | All eligible |
| Output | Description | Description | Measurement and some comparison | Comparison | Regional and international variance; quality assurance; risk stratification and adjustment |
| Procedure | Inception | Development | Refinement | Fully evolved | Fully evolved |
| Method | Structured case report | Prospective development study | Prospective cohort study; feasibility or explanatory RCT | RCT | Registries and databases |
| Outcomes | Proof of concept; technical achievement; disasters; notable successes | Technical success; emphasis on safety and reproducibility | Safety; objective clinical and patient-reported outcomes | Objective clinical and patient-reported outcomes; cost-effectiveness | Rare events; long-term outcomes; quality assurance |
| Ethical approval | Yes, usually | Yes, always | Yes, always | Yes, always | Yes, always |
RCT, Randomized controlled trial.