CLOSURE: A Prospective, Single-Center Registry Evaluating the Safety and Performance of the Obtrua™ Neo Vascular Closure Device in Patients Undergoing Femoral Artery Puncture
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This is a prospective single center registry designed to evaluate the safety and performance of the Obtura Neo Vascular Closure Device in patients undergoing femoral artery puncture for diagnostic or interventional catheterization procedures. Femoral access remains widely used, and manual compression after sheath removal often requires prolonged bed rest and may be associated with access site complications. Vascular closure devices are developed to reduce time to hemostasis and allow early ambulation.
The study will include patients undergoing procedures using standard 6F 7F or 8F introducer sheaths with up to 12 cm working length. The primary endpoints include time to hemostasis and device deployment success at puncture closure. Deployment success will be defined as proper anchor delivery with effective hemostasis and no significant bleeding at the puncture site.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Both Male And Female Patients Aged 18 Years Or Older.
- •Patient Should Be Able To Provide Valid Informed Signed Consent.
- •Scheduled For Diagnostic Or Interventional Catheterization Procedures Using A Standard 6F Or 7F Or 8F Introducer Sheath With Up To 12 Cm Working Length.
- •Patient Is Willing And Able To Adhere To Data Collection And Follow Up Requirements.
排除标准
- •Patients Requiring Puncture Through A Vascular Graft Or A Repuncture At A Site Previously Punctured Within 48 Hours Or Planned Arterial Access At The Same Access Site Within 30 Days Of Catheterization.
- •Patients With A Bleeding Disorder, Including Thrombocytopenia With Platelet Count Less Than 100000, Or Thrombasthenia, Or Von Willebrand Disease, Or Significant Anemia With Hemoglobin Less Than 9 Mg Per Dl. Patients Who Bruise Or Bleed Easily Or With A History Of Significant Bleeding Or Platelet Disorders.
- •Patients With Allergy To Bovine Materials, Collagen And Or Collagen Products, Or Polyglycolic Or Polylactic Acid Polymers.
- •Patient With Significant Medical Illness Other Than Study Indication As Per Judgment Of Principal Investigator.
- •Patients Who Are Judged By Investigator As Unable To Ambulate Post Procedure Due To Physical Disability Or Significant Comorbidity Or Significant Medical Illness.
- •Patients Undergoing Thrombolytic Therapy Or Treated With Warfarin Within 24 Hours Prior To Catheterization.
- •Patients Who Are Known Or Suspected To Be Pregnant Or Are Lactating.
- •Patients With Uncontrolled Hypertension With Systolic Blood Pressure Greater Than 180 MmHg, Unless Systolic Pressure Can Be Lowered By Pharmacological Agents Prior To Closure.
- •Difficulty In Obtaining Vascular Access Resulting In Multiple Arterial Punctures And Or Posterior Arterial Puncture Or Evidence Of Systemic, Cutaneous, Or Groin Infection.
- •History Of Severe Claudication, Previous Limb Amputation Below The Access Site, An Iliac Or Femoral Artery Lesion Greater Than 50 Percent, Previous Vascular Bypass Surgery, Or Stent Placement Within 1 Cm From The Puncture Site.
- •Peripheral Artery Disease Patients Can Be Included At Operator Discretion Except If Heavy Calcification Is Present At The Access Site Which, At The Operator Discretion, Precludes Insertion Of The Vascular Closure Device.
研究者
Dr Rajiv C
Aster Medicity, Kochi