Role of preliminary registry data in development of a clinical trial for an innovative device: a small but integral piece of a health policy initiative

Figures & data

Figure 1. (a). Illustration of eCLIPs device in 3-D (left), side (middle) and plan (right) views. (b). Illustration of eCLIPs device deployed with anchor segment in sidebranch and leaf portion bridging the neck, behind which are coils delivered by catheter penetrating ribs of leaf portion.

Figure 2. Illustration of dual Y-stenting in bifurcation aneurysm glass model, showing triangular gap between stents and neck of aneurysm.

Figure 3. Graphic illustration of disposition of all patients considered for eCLIPs implantation from 2013 to 31 May 2016.

Figure 4. Raymond scores at index procedure and at follow-up in all patients reaching at least six-month anniversary after eCLIPs implantation.

Figure 5. Percentage of patients allocated to Raymond scores 1–3 at index procedure and at follow-up.

Table 1. Complications documented in all patients considered for implantation of eCLIPs device.

Complication	Number of patients	Comment
Death^2	3	2 giant^3;[27] 1 guide wire perforation^4
Stroke	1	Guide wire perforation^5
Transient ischemic attack	2	Transient cortical blindness; transient aphasia

Table 2. Procedural adverse events documented in all patients considered for implantation of eCLIPs device.

Adverse events	Number of patients	Comment
Dissection	1	Asymptomatic^6
Vasospasm	4	Asymptomatic; resolved with catheter removal and administration of vasodilating agent^7
Thrombotic event	2	Asymptomatic^8

Figure 6. Comparative follow-up data versus Index procedure (eCLIPs vs. stent assisted coiling, SAC).

Figure 7. Percentage of patients allocated to Raymond Scores 1–2 and 3 in spectrum of studies of devices used to manage wide-neck bifurcation aneurysms.

Chiu AH, De Vries J, O’Kelly C, et al. The second generation eCLIPs endovascular clip system: initial experience. J Neurosurg. Forthcoming.

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