Atherosclerotic Disease Clinical Trial
Official title:
Ranger DEB All Comers Registry - Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter: An All Comers Registry.
NCT number | NCT02462005 |
Other study ID # | Ranger SFA Registry |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2015 |
Est. completion date | May 2019 |
Verified date | January 2020 |
Source | Klinikum Arnsberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
A total of up to 250 patients from an all-comers patient population with infrainguinal
atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug
coated balloon.
Interim analysis will be carried out for every 50 subjects enrolled.
Status | Completed |
Enrollment | 171 |
Est. completion date | May 2019 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age = 18 years. - Patient must be willing to sign a a patient informed consent form. - Patient with de novo, restenotic or reoccluded lesions in the infrainguinal .arteries implanted or scheduled for an implant with a Ranger Drug coated balloon. - Target vessel reference diameter 2.5 to 8 mm. Exclusion Criteria: - Subjects pregnant or planning to become pregnant during the course of the study. - Life expectancy of less than 1 year. - Known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications. Subject enrolled in another study that has not reached its primary endpoint at the time of enrolment. |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Hochsauerland, Karolinen-Hospital | Arnsberg | |
Germany | Knappschaftskrankenhaus Bottrop | Bottrop | |
Germany | SRH Klinikum Karlsbad-Langensteinbach GmbH | Karlsbad-Langensteinbach | |
Germany | Gefaesspraxis im Tal | Muenchen | |
Germany | Krankenhaus der Barmherzigen Brüder Trier | Trier | |
Switzerland | CHUV, Service de Chirurgie Vasculaire | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Klinikum Arnsberg | Boston Scientific Corporation |
Germany, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical primary endpoint: Major Adverse Events (MAE) defined as composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 6 months post-index procedure. | 6 Months | ||
Primary | Performance primary endpoint: Primary patency at 12 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention | 12 Months | ||
Secondary | Primary patency at 6 and 24 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention | 6 and 24 Months | ||
Secondary | MAE at 12 and 24 months | 12 and 24 Months | ||
Secondary | Technical success, defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with = 50% residual stenosis (visual assessment) | Intraoperative | ||
Secondary | Device success, defined as exact deployment of the device according to the IFU (operator assessment) | Intraoperative | ||
Secondary | Procedural success, defined as the combination of technical success and device success | Intraoperative | ||
Secondary | Ankle-Brachial Index (ABI) at 6, 12 and 24 months (and prior to any reintervention) | 6, 12 and 24 months | ||
Secondary | Improvement of at least one Rutherford class at 6, 12 and 24 months (an prior to any reintervention) compared to the pre-procedure Rutherford classification. | 6, 12 and 24 months | ||
Secondary | Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 6, 12 and 24 months. | 6, 12 and 24 months | ||
Secondary | Limb salvage, defined as preservation of the treated limb with no need for any amputation at 6, 12 and 24 months. | 6, 12 and 24 months | ||
Secondary | Improvement of pain score at 6, 12 and 24 months compared to the pre-procedure score | 6, 12 and 24 months |
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