Early Vessel Recoil Following Below-the-knee (BTK) Artery Treatment With the Spur Peripheral Retrievable Scaffold System in Specific Patient Populations With Chronic Limb-threatening Ischemia (CLTI) - The DEEPER CHALLENGE Single Center Prospective Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Medical University of Graz
- Enrollment
- 40
- Primary Endpoint
- Vessel recoil assessed with angiography
Overview
Brief Summary
Chronic limb threatening ischemia (CLTI) represents the most advanced stage of peripheral arterial disease (PAD) and is characterized by ischemic rest pain, non-healing wounds, or ischemic gangrene. High-risk PAD populations including patients with end-stage renal disease and or diabetes also experience worse outcomes with significantly increased rates of amputation and mortality.
Although some patients with PAD are best treated with a combination of medical management, exercise and lifestyle modification, revascularization is indicated in those with advanced stages of disease and particularly in the presence of CLTI. Revascularization of below-the-knee (BTK) arteries is required for most patients suffering from CLTI, but treatment faces numerous challenges comprising calcification, small vessel size, long-lesion length and early elastic recoil. With regard to these challenges, numerous innovative techniques and devices have been developed within the past decades to optimize endovascular treatment of BTK vessels.
The Spur Peripheral Retrievable Scaffold System (Spur) was developed to directly address many of these pitfalls of infrapopliteal arterial disease. The premise of the design of the Spur is to provide temporary mechanical scaffolding and to prepare the vessel for treatment with a drug-coated balloon (DCB) to enhance drug absorption by creating channels in the endothelium by the deployed Spur.
The objective of this study is to perform a prospective, single-center, single-arm, non-randomized study to evaluate acute vessel recoil following BTK treatment with the Spur Retrievable Scaffold System in combination with a commercially available DCB in specific patients populations. Specific patient populations that are selected to participate in this study are either at high risk to discover unfavorable outcomes with standard techniques due to a high complexity of lesions and/or patients that are not adequately mirrored in available studies. The patient cohorts that will be studied are diabetics and patients on hemodialysis (for at least 6 months). As women are commonly under-represented in comparable trials, this study requires at least 50% of women for each cohort.
The primary endpoint is vessel recoil within 15 minutes post treatment assessed with angiography. Secondary endpoints will be followed out to 12 months.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •General Inclusion Criteria:
- •Subject is willing and able to provide informed consent
- •Subject is able to comply with the study protocol and with follow-up
- •Life expectancy \>1 year in the investigator's opinion
- •Subject is \> 18 years of age
- •Subject must have symptoms of limb ischemia, determined by clinical symptoms of RC 4 or 5, including rest pain (RC 4) and/or minor tissue loss (RC 5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation
- •Subject has stenotic, restenotic or occlusive lesions located in BTK vessels in pre-screening with CTA, MRA or angiography prior to the index procedure.
- •Subject suffers from diabetes and/or receives chronic hemodialysis for KD (for at least 6 months)
- •Diabetes cohort: Subject requires for estimated glomerular filtration rate (eGFR) ≥ 25ml/min (within 30 days of procedure)
- •Hemodialysis cohort: Subject has been receiving hemodialysis treatment for ≥ 6 months. (Note: subjects with diabetes who also receive chronic hemodialysis will be excluded from the diabetes cohort and will be included only in the hemodialysis cohort).
Exclusion Criteria
- •Subject is unwilling or unlikely to comply with the duration of the study (up to 12 months +/-30 days post intervention) in the opinion of the investigator
- •Subject is pregnant or planning to become pregnant during the course of the trial
- •Subject is breastfeeding or planning to breastfeed during the course of the trial
- •Subject has an active and uncontrolled systemic infection, including septicemia or bacteremia
- •Subject has documented active osteomyelitis proximal to the phalanges of the target limb. Osteomyelitis in the digit(s) of the target foot is permitted.
- •Subject has a wound above the ankle and/or a heel wound
- •Subject has planned or had previous major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal amputation or digit amputation) is permitted.
- •Subject with poor and insufficient general condition and/or comorbidities not allowing for endovascular treatment as per the investigator's discretion
- •Diabetes cohort: subject has impaired renal function as defined by an eGFR \< 25 mL/min within 30 days of procedure
- •Hemodialysis cohort: subject has been receiving hemodialysis treatment for less than 6 months
Arms & Interventions
CLTI patients on chronic hemodialysis
Intervention: Vessel recoil measurement 15 minutes post final treatment (angiographically) (Other)
CLTI patients with diabetes
Intervention: Vessel recoil measurement 15 minutes post final treatment (angiographically) (Other)
Outcomes
Primary Outcomes
Vessel recoil assessed with angiography
Time Frame: 15 minutes post treatment
Secondary Outcomes
- Freedom from clinically driven target lesion revascularisation (CD-TLR)(Up to 12 months)
- Target vessel patency determined by duplex ultrasound (DUS)(30 days)
- Change in ankle brachial index (ABI, or toe brachial index (TBI) alternatively) from baseline(30 days)
- Change in Rutherford Class from baseline(30 days)
- Freedom from unplanned major (above the ankle) amputation(Up to 12 months)
- Freedom from major adverse limb events (MALE)(Up to 12 months)
- Freedom from all-cause mortality(Up to 12 months)
- Change in Wound, Ischemic, and foot Infection score (WIfI) from baseline(30 days)