PRET: Patients Prone to Recurrence After Endovascular Treatment

NCT00626912 | Completed Phase 4 Results DMC

• 1 other identifier: ND07.001
• Study Type: interventional
• Target: 447
• Locations: 6 countries
• Sites: 32

Brief Summary

The PRET study aims at comparing two types of coils used in the endovascular treatment of intracranial aneurysms. The first type made of platinum has been used for more than 15 years. The other, referred to as hydrocoil, containing in addition to platinum a polymer layer that expands when in contact with blood, has been in use since 2002. The hypothesis of the PRET study is that the newer hydrocoil will be more effective and yet as safe as the older platinum coil.

Conditions

Intracranial Aneurysm; Subarachnoid Hemorrhage

Keywords

large aneurysm; recurrence; hydrocoil

Outcome Measures

Primary Outcomes (1)

• Recurrence Rate of Target Aneurysm.

  1. major angiographic recurrence of the lesion or the presence of a residual aneurysm at last angiographic follow-up, as determined by the core laboratory, blinded to treatment allocation; 2. retreatment of the same aneurysm by endovascular or surgical means during the 18-month follow-up period; 3. an intracranial bleeding episode, or the occurrence or progression of a mass effect in relation to the treated aneurysm during the follow-up period, as determined by the blinded Adverse Event Committee.

  18 months

Secondary Outcomes (3)

• Mortality Rate

  18 months

• Number of Participants With Adverse Events

  18 months

• Number of Participants With Serious Adverse Events

  18 months

Study Arms (2)

1

ACTIVE COMPARATOR

platinum coils

Procedure: endovascular coil embolization

2

ACTIVE COMPARATOR

hydrogel coils

Procedure: endovascular coil embolization

Interventions

endovascular coil embolization PROCEDURE

standard endovascular coil embolization with or without adjunct techniques

Also known as: platinum coil, hydrogel coil

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting at least one aneurysm 'prone to recurrence after endovascular treatment' (PRET), defined for the sake of this study as:
• PRET-1: One ruptured or unruptured aneurysm, never treated, with a dimension ≥10mm (longest axis, including thrombosed portions of large or giant aneurysms); for ruptured lesions, patients should be in WFNS grade I, II or III.
• PRET-2: an Aneurysm presenting a major recurrence after previous coiling; and judged by the neurovascular team to require elective treatment.
• The anatomy of the lesion is such that endovascular treatment is possible with both types of coils (not necessarily certain or probable)
• The endovascular physician is content to use either type of coils (platinum or hydrogel-coated coils) but no other type of coils
• Patient is 18 or older
• Life expectancy is more than 2 years

You may not qualify if:

• Presence of other aneurysms requiring treatment during the same session
• Patients with associated cerebral arteriovenous malformations
• When parent vessel occlusion, without simultaneous endosaccular coiling of the aneurysm, is the primary intent of the procedure
• Any absolute contraindication to endovascular treatment, angiography, or anaesthesia such as severe allergies to contrast or medications

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (32)

Shands - University of Florida Hospital

Gainesville, Florida, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, United States

Location

University of Mississipi Health Care

Jackson, Mississippi, 39216, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Location

Washington University in St Louis

St Louis, Missouri, United States

Location

University of Buffalo (SUNY)

Buffalo, New York, United States

Location

Stony Brook University Medical Center (SUNY)

Stony Brook, New York, United States

Location

SUNY Upstate Medical University

Syracuse, New York, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Location

Cleveland Clinic

Cleveland, Ohio, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Location

Oregon Health and Science University

Portland, Oregon, United States

Location

Medical University of South Carolina

Charleston, South Carolina, United States

Location

The Methodist Hospital

Houston, Texas, United States

Location

University of Virginia Health System

Charlottesville, Virginia, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital

Montreal, Quebec, H2L 4M1, Canada

Location

Instituto de Neurocirugía Dr. Asenjo

Santiago, Chile

Location

CHU Bordeaux - Hôpital Pellegrin

Bordeaux, France

Location

CHU Henri Mondor - Hôpital Henri Mondor

Créteil, France

Location

CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, France

Location

CHU Nancy-Hôpital Central

Nancy, France

Location

CHU de Nantes - Hôpital Guillaume et René Laennec

Nantes, France

Location

Centre Hospitalier Sainte Anne

Paris, France

Location

Kobe City Medical Center General Hospital

Kobe, Japan

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

The Walton Centre NHS Foundation Trust

Liverpool, United Kingdom

Location

Queens Medical Centre

Nottingham, United Kingdom

Location

Related Publications (1)

• Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2. No abstract available.

  PMID: 24849854 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm; Subarachnoid Hemorrhage; Recurrence

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Limitations and Caveats

Operators could not be blinded to coil type. This may have affected case selection, coil selection, and completeness of the coiling procedure. Aneurysm volumes were not directly measured but extrapolated from aneurysm dimensions.

Results Point of Contact

• Title: Ruby Klink, coordinator
• Organization: Centre de Recherches du Centre Hospitalier de l'Université de Montréal

ruby.klink@crchum.qc.ca

(514) 890 8000

Study Officials

• Jean RAYMOND, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  STUDY CHAIR

• Daniel ROY, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: February 29, 2008
• Study Start: June 1, 2007
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 26, 2019
• Results First Posted: March 1, 2019

Record last verified: 2016-07

Locations

FR (6); CA (3); GB (3); US (18); CL (1); JP (1)