Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH Feasibility Study)
Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System for Bifurcation Lesions (First-in-Human, Feasibility Study)
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
This is a prospective, single-arm, single-center initial feasibility clinical study enrolling subjects with symptomatic ischemic heart disease due to a de novo coronary bifurcation lesion. The objective is to obtain initial insights into the clinical safety of the device-specific aspects of the procedure; whether the device can be successfully delivered and implanted; whether there are any operator technique challenges with device use; human factors; clinical safety of the device and whether the device performs in accordance with its intended purpose.
All enrolled subjects will be treated with the study device during the index procedure and followed after treatment to assess procedural success, clinical safety, and device performance. Follow-up is conducted through 3 years.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Asunción、パラグアイ
- Cirugía Cardiovascular, Sanatorio Italiano
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Be 21 years of age or older. Have symptomatic ischemic heart disease or objective evidence of reduced blood flow to the heart.
Be eligible for PCI, also known as coronary stenting. Have a new coronary artery narrowing involving a branch point that meets the study's angiographic requirements.
Be willing and able to complete study follow-up. Be able to provide written informed consent. If able to become pregnant, have a negative pregnancy test before the procedure and agree not to become pregnant or breastfeed for 1 year.
Exclusion Criteria:
Are currently participating in another investigational drug or device study that could interfere with this study.
Had a coronary intervention within 30 days before the planned study procedure. Need a planned additional coronary procedure soon after the study procedure. Had a prior stent placed close to the target lesion. Have a target lesion that requires certain other treatment devices before stent placement, other than balloon angioplasty or intravascular lithotripsy.
Have a serious medical condition that could limit participation, follow-up, or interpretation of the study results.
Have a life expectancy of less than 3 years. Have a condition requiring chronic immunosuppressive therapy or have a severe autoimmune or immunosuppressive condition.
Have significantly reduced heart pumping function. Had a recent acute heart attack, unless certain laboratory values have returned to acceptable levels.
Had a stroke or transient ischemic attack within the past 6 months. Have certain abnormal blood test results, including low white blood cell count, low neutrophil count, low platelet count, or significantly reduced kidney function.
Have active stomach or intestinal bleeding, active peptic ulcer disease, a bleeding disorder, or cannot receive blood transfusions.
Have a known allergy or contraindication to required medications, contrast dye, or study device materials that cannot be adequately managed.
Are pregnant, breastfeeding, or planning to become pregnant within 1 year after the study procedure.
Have coronary anatomy that is not suitable for the study device, as determined during coronary angiography (This may include blood clot in the target lesion, severe vessel tortuosity, severe calcification, certain lesion locations, or other significant disease in the target vessel).
Are unable or unwilling, in the opinion of the study doctor, to comply with the study requirements.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：デバイスの実現可能性
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Patients with coronary bifurcation lesions
Patients undergoing PCI to treat a bifurcation lesion
|
The MD-SBA DES System is a single use, minimally invasive combination product that consists of a cobalt chromium metal coronary stent, coated with sirolimus in a PEA/BHT matrix, on a rapid exchange (RX) delivery system.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Procedure Success
時間枠：Periprocedural
|
To determine whether the device can be successfully delivered and implanted, as measured by attainment of <30% final residual stenosis of the target lesion and no in-hospital major adverse cardiac events (MACE).
|
Periprocedural
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
MACE
時間枠：30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
|
Percentage of subjects with major adverse cardiac events, defined as cardiac death, myocardial infarction, emergency coronary artery bypass surgery, or clinically driven target lesion revascularization.
Components of MACE, including cardiac death and myocardial infarction, may also be summarized.
|
30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
|
|
TVF
時間枠：30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
|
Percentage of subjects with target vessel failure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization.
|
30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
|
|
Target Lesion Revascularization of the Side Branch
時間枠：30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
|
Percentage of subjects requiring repeat treatment of the side branch by percutaneous or surgical methods.
|
30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
|
|
Stent thrombosis
時間枠：6-months, 1-year, 2-years, and 3-years post index procedure
|
Percentage of subjects with late stent thrombosis.
|
6-months, 1-year, 2-years, and 3-years post index procedure
|
|
Acute Success
時間枠：Index procedure
|
Percentage of subjects with successful device delivery and target lesion treatment, including final residual stenosis <30% and adequate side branch flow.
|
Index procedure
|
|
Side Branch Access
時間枠：Index procedure
|
Percentage of subjects with TIMI-3 flow in the side branch and/or need to re-cross the side branch after study device use.
|
Index procedure
|
|
Bleeding / Vascular Complications
時間枠：Hospital discharge
|
Percentage of subjects with bleeding or vascular complications.
|
Hospital discharge
|
|
Procedure Time
時間枠：Index procedure
|
Duration of the index procedure in minutes
|
Index procedure
|
|
Fluoroscopy Time
時間枠：Index procedure
|
Total fluoroscopy duration during index procedure in minutes
|
Index procedure
|
|
Contrast Volume
時間枠：Index procedure
|
Total volume of contrast media used during index procedure in milliliters
|
Index procedure
|
協力者と研究者
捜査官
捜査官
- スタディディレクター：Randy E David, PhD、Advanced Bifurcation Systems Inc.
- スタディチェア：Mehran Khorsandi, MD、Advanced Bifurcation Systems Inc.
- 主任研究者：Adrian Ebner, MD、Sanatorio Italiano, Asunción, Paraguay
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- 082825
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。