Intrasaccular remodeling: clinical evidence from NECC and CONTRA studies
The clinical footprint of intrasaccular devices is expanding through rigorous prospective research. The NECC trial, a US-based prospective IDE study co-led by Pascal Jabbour, enrolled 250 patients with ruptured and unruptured aneurysms. Interim data reveals an adequate occlusion rate close to 76%, with a strong 96% rate of freedom from retreatment. On the safety front, the trial demonstrated an overall complication rate of just 3% and zero device-related mortality.
Addressing whether the Contour Neurovascular System ™ can be safely deployed in acute phases, Jens Fiehler presented data from the European CONTRA study. Evaluating 83 ruptured aneurysms across high-volume centers, the study confirmed:
- High acute efficacy: A preliminary 12-month complete occlusion rate around 86% was recorded, with no safety warning signals or acute phase risks.
- Structural stability: The study introduced a new classification system for intrasaccular devices, demonstrating that the Contour implant exhibits exceptional structural stability with no neck coverage migration over the first six months.
Assessing device stability and the upcoming DELIVER-I Registry
A major technical discussion revolves around combining intrasaccular implants with adjunct coils. Similar to flow diversion strategies, while additional coiling is not formally indicated and the CONTRA data showed no long-term statistical benefit, operators occasionally use a few coils based on individual anatomy or procedural comfort.
To resolve clinical discrepancies, robust real-world evidence is required. To achieve this, the upcoming DELIVER-I multi-center registry will monitor a wide array of intrasaccular devices, capturing comprehensive performance data across diverse patient cohorts and bridging the gap between controlled clinical trials and daily neurointerventional practice.
