Endovascular embolization of 150 basilar tip aneurysms with Guglielmi detachable coils: results of the Food and Drug Administration multicenter clinical trial

1998 ◽  
Vol 5 (4) ◽  
pp. E3 ◽  
Author(s):  
Joseph M. Eskridge ◽  
Joon K. Song ◽  
_ _
Keyword(s):  
Clinical Trial ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
Guglielmi Detachable Coils ◽  
Unruptured Aneurysms ◽  
Ruptured Aneurysms ◽  
Platinum Coil ◽  
Detachable Coils

To assess the safety and efficacy of aneurysm embolization performed using Guglielmi detachable coils (GDCs), the authors reviewed the results of a cohort of 150 patients with either ruptured (83 patients) or unruptured (67 patients) basilar tip aneurysms treated with these detachable platinum coil devices in the early part of the United States multicenter GDC clinical trial that led to Food and Drug Administration approval for the device. The most common presentation in this cohort of patients was headache (53%). All patients were entered into the trial after neurosurgical assessment excluded them as candidates for surgical clipping of their aneurysms. Greater than 90% coil packing was achieved in 75% of the patients. For those patients in whom follow-up information was available, the mean angiographic and clinical evaluation follow-up time for 61 patients with ruptured aneurysms was 13.7 months (range 0-43 months) and that for the 49 patients with unruptured aneurysms was 9.8 (range 0-40 months). Conservative mortality rates included up to 23% for the ruptured aneurysm group and up to 12% for the unruptured aneurysm group; the rebleeding rate for treated ruptured aneurysms was up to 3.3% and the bleeding rate for unruptured aneurysms up to 4.1%. Permanent deficits due to stroke in patients with ruptured or unruptured aneurysms occurred in up to 5% and 9%, respectively. Vasospasm occurred in 8% of the patients; it was associated with two deaths. Periprocedural mortality was 2.7% (four patients with ruptured aneurysms). Detachable platinum coil embolization is a promising treatment for ruptured basilar tip aneurysms that are not surgically clippable; in selected patients it offers lower incidences of morbidity and mortality compared with conservative medical management. The role of this procedure in unruptured basilar tip aneurysms is unclear with less supportive results. More long-term follow-up evaluation is necessary and results are expected to improve.

Endovascular embolization of 150 basilar tip aneurysms with Guglielmi detachable coils: results of the Food and Drug Administration multicenter clinical trial

1998 ◽  
Vol 89 (1) ◽  
pp. 81-86 ◽  
Author(s):  
Joseph M. Eskridge ◽  
Joon K. Song ◽  
_ _
Keyword(s):  
Clinical Trial ◽  
Drug Administration ◽  
Guglielmi Detachable Coils ◽  
Content Type ◽  
Unruptured Aneurysms ◽  
Ruptured Aneurysms ◽  
Platinum Coil ◽  
Detachable Coils ◽  
Fine Print

Object. To assess the safety and efficacy of aneurysm embolization performed using Guglielmi detachable coils (GDCs), the authors reviewed the results of a cohort of 150 patients with either ruptured (83 patients) or unruptured (67 patients) basilar tip aneurysms treated with these detachable platinum coil devices in the early part of the United States multicenter GDC clinical trial that led to Food and Drug Administration approval for the device. Methods. The most common presentation in this cohort of patients was headache (53%). All patients were entered into the trial after neurosurgical assessment excluded them as candidates for surgical clipping of their aneurysms. Greater than 90% coil packing was achieved in 75% of the patients. For those patients in whom follow-up information was available, the mean angiographic and clinical evaluation follow-up time for 61 patients with ruptured aneurysms was 13.7 months (range 0–43 months) and that for the 49 patients with unruptured aneurysms was 9.8 (range 0–40 months). Conservative mortality rates included up to 23% for the ruptured aneurysm group and up to 12% for the unruptured aneurysm group; the rebleeding rate for treated ruptured aneurysms was up to 3.3% and the bleeding rate for unruptured aneurysms up to 4.1%. Permanent deficits due to stroke in patients with ruptured or unruptured aneurysms occurred in up to 5% and 9%, respectively. Vasospasm occurred in 8% of the patients; it was associated with two deaths. Periprocedural mortality was 2.7% (four patients with ruptured aneurysms). Conclusions. Detachable platinum coil embolization is a promising treatment for ruptured basilar tip aneurysms that are not surgically clippable; in selected patients it offers lower incidences of morbidity and mortality compared with conservative medical management. The role of this procedure in unruptured basilar tip aneurysms is unclear with less supportive results. More long-term follow-up evaluation is necessary and results are expected to improve.

scholarly journals Angiographic Follow-up of Embolization Using Guglielmi Detachable Coils for Cerebral Aneurysms

2003 ◽  
Vol 9 (1_suppl) ◽  
pp. 47-50 ◽  
Author(s):  
Y. Nakai ◽  
M. Sonobe ◽  
K. Sugita ◽  
Y. Matsumaru
Keyword(s):  
Morphological Changes ◽  
Cerebral Aneurysms ◽  
Guglielmi Detachable Coils ◽  
Complete Occlusion ◽  
Unruptured Aneurysms ◽  
Ruptured Aneurysms ◽  
Detachable Coils ◽  
Aneurysm Occlusion

The purpose of this study is to evaluate the mid or long-term angiographical stability of Guglielmi Detachable Coils (GDC) after embolization for cerebral aneurysms. Between march 1997 and november 2001, 164 aneurysms, including 116 ruptured and 48 unruptured aneurysms, were treated using GDC at Mito National Hospital. Cerebral angiograms over one month after embolization were obtained in 111 aneurysms, including 71 ruptured and 40 unruptured aneurysms. At the time of initial GDC embolization of the 71 ruptured aneurysms, complete occlusion was achieved in 31 aneurysms, neck remnant in 18 aneurysms, and body filling in 22 aneurysms. Morphological changes were observed in 26 aneurysms (37%) in follow-up. Progressive thrombosis was obtained in 12 out of 71 aneurysms, no changes were shown in 45, and recanalizations occurred in 14. In the initial embolization of the 40 unruptured aneurysms, complete occlusion was achieved in 15 aneurysms, neck remnant in five and body filling in 20 aneurysms respectively. Morphological changes were observed in 12 aneurysms (30%), in which 12 aneurysms showed progressive thrombosis and 28 aneurysms were unchanged. There were significant differences of the long-term angiographical stability between ruptured and unruptured aneurysms. Rigorous follow-up angiography is mandatory when complete aneurysm occlusion is not achieved in ruptured aneurysms.

scholarly journals Angiographical Change of Guglielmi Detachable Coils

2004 ◽  
Vol 10 (1_suppl) ◽  
pp. 161-166 ◽  
Author(s):  
Y. Nakai ◽  
M. Sonobe ◽  
T. Takigawa ◽  
T. Yamazaki ◽  
S. Okamoto ◽  
...  
Keyword(s):  
Cerebral Aneurysm ◽  
Medical Condition ◽  
Cerebral Aneurysms ◽  
Acute Stage ◽  
Guglielmi Detachable Coils ◽  
Unruptured Aneurysms ◽  
Detachable Coils

Acute angiographical changes for preventing acute rebleeding on GDC treated cerebral aneurysms were evaluated. From December 2000 to November 2002, 48 total aneurysms in 44 consecutive patients with acute SAH. Acute angiographical evaluations were carried out in 46 aneurysms, including 42 ruptured and 4 unruptured aneurysms. Two cases were excluded because of poor medical condition. In this series, there were no rebleeding cases in acute stage. In the initial embolization for the 46 aneurysms, CO was achieved in eight aneurysms, NR in 15 aneurysms and BF in 23 aneurysms. Acute angiographical observations showed progressive thrombosis in 17 aneurysms (37%). No changes were observed in remaining 29. No recanalization was observed in this series. Only one case of BF, inside the aneurysm bleb was still observed during follow up. Additional embolization was carried out. Progressive thrombosis was frequently observed in GDC treated cerebral aneurysms during acute stage. This angiographical finding seems to show prevention of rebleeding, which is considered important for the management of GDC treatment in acutely ruptured cerebral aneurysm.

Treatment of basilar artery bifurcation aneurysms by using Guglielmi detachable coils: a 6-year experience

1999 ◽  
Vol 90 (5) ◽  
pp. 843-852 ◽  
Author(s):  
Gerhard Bavinzski ◽  
Monika Killer ◽  
Andreas Gruber ◽  
Andrea Reinprecht ◽  
Cordell E. Gross ◽  
...  
Keyword(s):  
Basilar Artery ◽  
Thrombotic Complication ◽  
Guglielmi Detachable Coils ◽  
Content Type ◽  
Unruptured Aneurysms ◽  
Poor Grade ◽  
Long Term Follow Up ◽  
Detachable Coils ◽  
Fine Print

Object. The authors retrospectively analyzed the results of their 6-year experience in the treatment of basilar artery (BA) bifurcation aneurysms by using Guglielmi detachable coils (GDCs).Methods. This analysis involved 45 BA tip aneurysms in 16 men and 29 women who ranged in age from 23 to 78 years (mean 50 years). Seventy-five percent of the aneurysms had ruptured and 25% remained unruptured. Of the group whose aneurysms hemorrhaged, 14 patients were Hunt and Hess Grade I or II and 20 were Hunt and Hess Grades III to V; 32 patients were treated within 2 weeks of their subarachnoid hemorrhage (SAH). Initially, treatment with GDCs was limited to poor-grade high-risk patients who refused surgery or patients in whom surgery proved unsuccessful. Later in the study, good-grade patients with narrow-necked aneurysms were also treated using GDCs.The length of clinical follow up ranged from 1 to 72 months (average 27.4 months) in the 37 surviving patients. In 33 of the 45 aneurysms treated with coil placement, good to excellent results were achieved. There were 12 poor results (27%) including one in a patient from the non-SAH group who suffered a thrombotic complication due to an underlying vasculitis. Eight deaths were recorded in this group of 45 patients. One of these deaths was caused by a complication related to anesthesia, one by unknown causes, and six resulted from complications of the disease. One patient rebled on the 2nd day after the endovascular procedure. The mortality and permanent morbidity rates directly related to the intervention were 2.2% and 4.4%, respectively.Angiographic studies obtained immediately postintervention demonstrated 99 to 100% occlusion in 30 (67%) of the aneurysms; nine (20%) were more than 90% occluded; and six (13%) were less than 90% occluded by the GDCs. Follow-up angiograms were obtained in 31 patients between 2 and 72 months after coil placement. Nineteen (61%) of the follow-up angiograms revealed stable results (that is, no change from initial treatment). Twelve of the 31 showed coil compaction, but only eight of these lesions could accept additional coils.In large aneurysms recanalization was seen in 57%, and some of the larger lesions required as many as four embolizations (mean 1.7) to achieve optimal occlusion. When small-necked aneurysms were analyzed as a subset, a stable angiographic result was seen in 92%.Conclusions. Use of GDCs led to excellent clinical and angiographic results in the majority of patients with BA tip aneurysms included in this limited follow-up study. Rebleeding was encountered in one of the 34 previously ruptured BA aneurysms treated with GDCs, and no hemorrhages have been documented in the 11 unruptured aneurysms treated with GDCs in this series. Long-term follow-up studies are necessary before it is possible to compare adequately the treatment of aneurysms with coil placement to the gold standard of aneurysm clipping.

INITIAL EXPERIENCE WITH BIOACTIVE CERECYTE DETACHABLE COILS

Neurosurgery ◽  
2008 ◽  
Vol 62 (4) ◽  
pp. 799-806 ◽  
Author(s):  
Erol Veznedaroglu ◽  
Christopher J. Koebbe ◽  
Adnan Siddiqui ◽  
Robert H. Rosenwasser
Keyword(s):  
Coil Embolization ◽  
Unruptured Aneurysms ◽  
Handling Characteristics ◽  
Platinum Coil ◽  
Detachable Coils ◽  
Mean Size ◽  
Endovascular Coil Embolization ◽  
The Mean ◽  
Permanent Neurological Deficit

Abstract OBJECTIVE Despite proven safety of endovascular coil embolization of intracranial aneurysms, the potential need for retreatment remains criticized. The goal of this prospective study was to assess the safety, durability, and effect on recanalization rates of the Cerecyte (Micrus Corp., Sunnyvale, CA) bioactive coil. METHODS Two hundred twelve ruptured and unruptured aneurysms in 176 patients were prospectively enrolled in a database registry during a 12-month period. Adverse clinical outcomes directly attributed to the use of the Cerecyte coil were documented. Angiographic outcomes were determined immediately after coil embolization and during follow-up studies. All patients who received stent assistance or a non-Cerecyte coil were excluded. Two independent endovascular surgeons reviewed follow-up films. Any discrepancy was deemed a recurrence. RESULTS After exclusion criteria, 81 patients with 89 aneurysms were available for a minimum of 6 months of follow-up. Of those 89 aneurysms, 65% were ruptured aneurysms and were treated in the acute setting. The mean size of the aneurysm was 7 mm. The mean angiographic follow-up period was 11.2 months. Recurrences requiring retreatment as a result of dome filling were identified in six aneurysms (6.7%). Four aneurysms (4%) developed compaction of more than 20%, which was defined as interstitial filling of the fundus. There was one thromboembolic event leading to permanent neurological deficit. No cases of chemical meningitis or delayed hydrocephalus occurred. CONCLUSION The Cerecyte bioactive coil seems to be safe and effective for use in both ruptured and unruptured aneurysms. The bioactive polymer within the coils allows similar handling characteristics of a bare platinum coil. Studies to assess long-term outcomes with direct comparison to platinum coils and alternative bioactive coils are warranted.

scholarly journals Evaluation of the Stability of Small Ruptured Aneurysms with a Small Neck after Embolization with Guglielmi Detachable Coils

2006 ◽  
Vol 12 (1_suppl) ◽  
pp. 91-96 ◽  
Author(s):  
Y. Kai ◽  
J. Hamada ◽  
M. Morioka ◽  
S. Yano ◽  
J. Kuratsu
Keyword(s):  
Endovascular Surgery ◽  
Guglielmi Detachable Coils ◽  
Ruptured Aneurysms ◽  
Detachable Coils ◽  
The Mean ◽  
The Difference ◽  
The Stability ◽  
The Relationship ◽  
Ruptured Intracranial Aneurysms

It is difficult to predict the compaction of Guglielmi detachable coils (GDC) after endovascular surgery for aneurysms. Therefore, we studied the relationship between the coil packing ratio and compaction in 62 patients with acute ruptured intracranial aneurysms that were small (<10 mm) had a small neck (<4 mm) and were coil-embolized with GDC-10. We recorded the maximum prospective coil length, L, as the length that correspond with the volume of packed coils occupying 30% of the aneurysmal volume. L was calculated as L (cm) = 0.3 × a × b × c and the coil packing ratio expressed as packed coil length/L × 100, where a, b, and c are the aneurysmal height, length, and width in mm, respectively. Angiographic follow-up studies were performed at three months and one and two years after endovascular surgery. Of the 62 patients, 16 (25.8%) manifested angiographic coil compaction (ten minor and six major compactions); the mean coil packing ratio was 51.9 ± 13.4%. The mean coil packing ratio in the other 46 patients was 80.5 ± 20.2% and the difference was statistically significant (p<0.01). In all six patients with major compaction the mean packing ratio was below 50%. We detected 93.8% of the compactions within 24 months of coil placement. In patients with small, necked aneurysms, the optimal coil packing ratio could be identified with the formula 0.3 × a × b × c. The probability of compaction was significantly higher when the coil packing ratio was under 50%. To detect coil compaction post-embolization, follow-up angiograms must be examined regularly for at least 24 months.

scholarly journals Rupture of Aneurysms during and after Embolization with Guglielmi Detachable Coils

2001 ◽  
Vol 7 (1_suppl) ◽  
pp. 83-87 ◽  
Author(s):  
Y. Matsumaru ◽  
M. Sonobe ◽  
Y. Nakai ◽  
S. Takahashi ◽  
T. Nose
Keyword(s):  
The Other ◽  
Anterior Communicating Artery ◽  
Partial Occlusion ◽  
Guglielmi Detachable Coils ◽  
Total Occlusion ◽  
Unruptured Aneurysms ◽  
Ruptured Aneurysms ◽  
Detachable Coils ◽  
Partially Occluded ◽  
Subarachnoid Hemorrhages

Between March, 1997 and June, 2000, 104 aneurysms, including 75 ruptured and 29 unruptured aneurysms, were treated with Guglielmi detachable coils by 120 embolizations in our institution. Intraprocedual perforation occurred in four cases, representing 3.3% of the embolizations. Subsequently, two cases deteriorated, and the other two cases recovered completely without any deficit. Aneurysmal perforations mostly occurred in acutely ruptured aneurysms, small aneurysms less than 4 mm, anterior communicating artery aneurysms, or first coil delivery. Rebleedings in the acute period of subarachnoid hemorrhage occurred in four cases of partial occlusion due to aneurysmal morphology, such as a wide neck or an irregular shape. Rebleedings in the chronic period occurred in two cases, one of which rebled two months after partial occlusion, and the other of which rebled 27 months after nearly total occlusion. No subarachnoid hemorrhages documented from previously unruptured aneurysms occurred after embolizations. Insufficient embolization for ruptured aneurysms cannot prevent rebleeding, and partially occluded aneurysms and recurring aneurysms in the follow-up period require immediate re-treatment.

Transitioning a randomized controlled trial to a digital registry – experience from the TAILOR-PCI digital follow-up study on onboarding, engagement and geofencing consent rate

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Avram ◽  
D So ◽  
E Iturriaga ◽  
J Byrne ◽  
R.J Lennon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
The United States ◽  
Mobile App ◽  
Funding Source ◽  
Location Tracking ◽  
Main Trial ◽  
Phone Calls ◽  
Effective Manner ◽  
Research Platform

Abstract Background/Introduction TAILOR-PCI is the largest cardiovascular genotype-based randomized trial (NCT#01742117) investigating whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes after percutaneous coronary intervention (PCI). The TAILOR-PCI Digital Sub-Study tests the feasibility of extending original follow-up of 1 year to 2 years using state-of-the-art digital solutions. Deep phenotyping acquired during a clinical trial can be leveraged by extending follow-up in an efficient and cost-effective manner using digital technology. Purpose Our objective is to describe onboarding and engagement of participants initially recruited in a large, pragmatic, international, multi-center clinical trial to a digital registry. Methods TAILOR-PCI participants, within 23 months of their index PCI, were invited by letters containing a URL to the Digital Sub-Study website (http://tailorpci.eurekaplatform.org). These invitations were followed by phone calls, if no response to the letter, to determine reason for non-participation. A NIH-funded direct-to-participant digital research platform (the Eureka Research Platform) was used to onboard, consent and enroll participants for the digital follow-up. Participants were asked to answer health-related surveys at fixed intervals using the Eureka mobile app and desktop platform. To capture hospitalizations, participants could enable geofencing to allow background location tracking, which triggered surveys if a hospitalization was detected. Result(s) Letters were mailed to 893 of 929 eligible participants across 22 sites in the United States and Canada leading to 226 homepage visits and 118 registrations. There were 107 consents (12.0% of invited; mean age: 66.4±9.0; 19 females [18%]): 47 (44%) participants consented after the letter, 36 (34%) consented after the 1st call and 24 (22%) consented after a 2nd call. Among those who consented, 100 were eligible (7 did not have a smartphone) 81 downloaded the study mobile app and 73 agreed for geofencing (Figure 1). Among the 722 invited participants who were surveyed, 354 declined participation: due to lack of time (146; 20.2%), lack of smartphone (125; 17.3%), difficulty understanding (41; 5.7%), concern about using smartphone (34; 4.7%), concern of data privacy (14; 1.9%), concerns of location tracking (6; 0.8%) and other reasons (57; 7.9%). Conclusion Extended follow-up of a clinical trial using a digital platform is feasible but uptake in this study population was limited largely due to lack of time or a smartphone among participants. Based on data from other digital studies, uptake may also have been limited since digital follow-up consent was not incorporated at the time of consent for the main trial. Figure 1. Onboarding of the digital substudy Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Institute of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

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