Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT03559556
Eligibility Criteria:
Inclusion Criteria:
1. Documented AVM with draining vein(s).
2. Adequate renal function (serum Creatinine \< 1.5 mg/dl within 30 days of SRS) to undergo contrast CT and interventional cerebral arteriography on the same day, as determined by treating physicians.
3. AVM must be physically separated from the optic pathway, brainstem or spinal cord.
4. The maximum diameter of AVM nidus must be less than 3.5 cm and/or less than 12 cc.
5. Age ≥ 10 years.
6. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
6.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
7. Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
1. Patients without a documented AVM.
2. Patients with a contraindication to CT or MRI such as contrast allergy, kidney failure or implanted metal devices or foreign bodies or severe claustrophobia.
3. Use of Nephrotoxic drugs, such as gentamycin, high-dose nonsteroidal anti-inflammatory drugs, or certain chemotherapeutic drugs within 10 days of the procedure.
4. Psychiatric illness/social situations that would limit compliance with study requirements.
5. Patients must not be pregnant at the time of SRS treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
120 Years
Study:
NCT03559556
Study Brief:
Protocol Section:
NCT03559556