A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee (DEEPER OUS)
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|ClinicalTrials.gov Identifier: NCT03807531|
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : February 11, 2020
The purpose of this study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS). The TSS is intended for use in conjunction with a commercially available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.
This study is a prospective, non-randomized, multicenter, single arm trial, with sites in New Zealand, Germany, and Switzerland.
At least two and no more than 10 sites are expected to participate, with 100 subjects enrolled (no more than 40 at a single site).
The study follow up will take place over a period of 365 days. A vessel recoil substudy will be included for a select group of subjects.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: Temporary Spur Stent System||Not Applicable|
The purpose of this clinical study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS) for subjects with infrapopliteal arterial disease.
The Temporary Spur Stent System is intended for use in conjunction with a commercially available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.
The TSS has been developed to provide another treatment option for patients with Peripheral Arterial Disease (PAD), and Critical Limb Ischemia (CLI).
Up to 100 subjects will be treated with the Temporary Spur Stent System in conjunction with an approved Drug Coated Balloon (DCB). No less than 1 subject and no more than 40 subjects will be enrolled at a single site.
A vessel recoil substudy is included in the trial. The purpose of this study is to evaluate vessel recoil in a select group of subjects (no more than 10 per site, up to 35 subjects in total). This will be conducted by obtaining measurements using Optical Coherence Tomography (OCT), Intravascular Ultrasound (IVUS), or Quantitative Vascular Analysis (QVA) of the target vessel during the index procedure.
The statistical analysis for this trial will use as a comparator a performance goal derived from a meta-analysis of infrapopliteal balloon angioplasty. Descriptive statistics may be used to describe other data points.
Subjects will be asked to participate in a baseline evaluation visit, the index procedure, a 30 day follow up visit, a 90 day follow up visit, a 180 day follow up visit, and a 365 day follow up visit. The baseline evaluation and index procedure visits may be combined. At each follow up visit, the subject will undergo a physical exam with wound evaluation (if applicable) including pictures, a medication history and compliance review, Ankle Brachial and Toe Brachial Indices (ABI and TBI), a duplex ultrasound of the treated limb, review of symptoms, and Adverse Events (AE) assessment. Subjects may choose to withdraw from the study at any time, for any reason. If subjects choose to withdraw, they will be asked to undergo an unscheduled study visit consisting of the aforementioned procedures.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multicenter, non-randomized, single-arm study|
|Masking:||None (Open Label)|
|Official Title:||A Non-randomized Trial of the Temporary Spur Stent System for the Treatment of Lesions Located in the Infrapopliteal Arteries Outside of the United States|
|Actual Study Start Date :||July 11, 2019|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Treatment with TSS
This is a single-arm study. Participating subjects will be treated with the Temporary Spur Stent System (TSS)
Device: Temporary Spur Stent System
Participating subjects that meet inclusion and exclusion criteria will undergo treatment of infrapopliteal occlusions and stenoses with the Temporary Spur Stent System according to protocol guidelines
Other Name: G2-SPUR04X60, G2-SPUR03X60, G2-SPUR02x60
- Primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization) [ Time Frame: 6 months ]The primary performance endpoint will be primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization).
- Freedom from device and procedure-related death through 30 days post-procedure [ Time Frame: 30 days ]The primary safety endpoint is freedom from device and procedure-related death through 30 days post-procedure
- Freedom from clinically driven target lesion revascularization through 6 months post procedure. [ Time Frame: 6 months ]The secondary efficacy endpoint is freedom from clinically driven target lesion revascularization through 6 months post procedure.
- Decrease in Rutherford class score at 3, 6 and 12 months. [ Time Frame: 3, 6, and 12 months ]
The second secondary efficacy measurement is decrease in Rutherford class score at 3, 6 and 12 months. Rutherford score is a classification system for patients with peripheral vascular disease.
Categories are numbered from 0 to 6, with 0 being asymptomatic, and 6 being major tissue loss, functional foot no longer salvageable. Higher values are therefore considered a worse outcome.
Rutherford class zero: No symptoms; Rutherford class 1: Mild Claudication (minimal leg pain with ambulation) symptoms; Rutherford Class 2: Moderate Claudication (moderate leg pain with ambulation); Rutherford Class 3: Severe claudication (severe leg pain with ambulation); Rutherford Class 4: Ischemic Rest pain (leg pain at rest); Rutherford Class 5: Minor tissue loss (nonhealing ulcer, focal gangrene, diffuse pedal ischemia); Rutherford class 6: Major tissue loss (extending above the transmetatarsal TM level, functional foot no longer salvageable.
- Wound healing for subjects with Rutherford class 5 at 6 and 12 months, as assessed by the investigator using WIfI score and descriptive characteristics, including change in wound size measured by any decrease in wound surface area. [ Time Frame: 6 and 12 months ]
The third secondary efficacy endpoint is wound healing for subjects with Rutherford class 5 at 6 and 12 months, as assessed by the investigator using WIfI score and descriptive characteristics, including change in wound size measured by any decrease in wound surface area.
The WIfI classification scoring system is a grading system using a composite score of wound (W), ischemia (I), and foot infection (fi). These three different categories are graded from 0 to 3 with 0 being the best and 3 being the worst.
The total score will be provided (clinical stage 1-5), which is used to estimate the risk for major amputation at one year. Patients with a score of 1 are considered low risk, and patients with a score of 5 are considered high risk (foot not salvageable). Therefore, higher values are considered a worse outcome.
The composite score is calculated by adding up the score from each category.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807531
|Contact: Carolyn M Mascho, DNPemail@example.com|
|Contact: Teo Jimenezfirstname.lastname@example.org|
|Klinikum Hochsauerland Klinik für Angiologie||Not yet recruiting|
|Contact: Simone Müller Tel: +49 02932 952-244 821|
|Principal Investigator: Michael Lichtenberg, Dr. Med|
|Universitats Herzzentrum Bad Krozingen||Recruiting|
|Bad Krozingen, Germany|
|Contact: Verena Zähringer +49-07633 402-2431|
|Principal Investigator: Thomas Zeller, Dr. med|
|Contact: Nadine Richter +49-0341 - 97 18770|
|Principal Investigator: Dierk Scheinert, Dr. Med|
|Sub-Investigator: Andrej Schmimdt, Dr. Med|
|RoMed Klinikum Rosenheim||Not yet recruiting|
|Contact: Michaela Bauer +49 8031 365 3550|
|Principal Investigator: Tepe Gunnar, Dr. Med|
|Auckland City Hospital||Recruiting|
|Auckland, New Zealand, 1023|
|Contact: Helen Senior Research Clinical Coordinator +64 9 307 4949 ext 24756 email@example.com|
|Principal Investigator: Andrew Holden, MBChB|
|Ospedale di Lugano Civico||Recruiting|
|Contact: Jos van den Berg +41-091-811-6111|
|Principal Investigator: Jos van den Berg, MD, PhD|
|Principal Investigator:||Andrew Holden, MBChB||Auckland Hospital|