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Frequently Asked Questions (FAQ)
- How do I get started with RELAX (REvascularization of Leg Arteries with the Xpert™ stent)?
- Is there any payment for participation in the RELAX (REvascularization of Leg Arteries with the Xpert™ stent) registry?
- Why is RELAX (REvascularization of Leg Arteries with the Xpert™ stent) limited to the Xpert™ stent?
- Can I submit data from patients that I have already treated?
- My IRB has a fee for submitting protocols. How do I pay the fee?
- Do I have to consent the patient for RELAX (REvascularization of Leg Arteries with the Xpert™ stent) prior to treatment?
- What if I need to treat above the knee as well as BTK to adequately revascularize the patient?
- Can I combine different treatment modalities? What if I limit the Xpert™ stent to failed angioplasty or atherectomy?
- What if I treat more than one vessel BTK?
- I haven’t used the Xpert™ stent yet. Is that a problem?
- What type of follow-up and data collection is required?
- Do I have to repeat an angiogram at 6 months and one year?
- Will the RELAX (REvascularization of Leg Arteries with the Xpert™ stent) data be available to me?
How do I get started with RELAX (REvascularization of Leg Arteries with the Xpert™ stent)?
Complete the site questionnaire and confidentiality agreement and return by fax. 50 sites will be approved. The updated protocol and ICD will be sent to the approved sites for submission to the IRB.
Is there any payment for participation in the RELAX (REvascularization of Leg Arteries with the Xpert™ stent) registry?
No. RELAX (REvascularization of Leg Arteries with the Xpert™ stent) is a physician sponsored real world registry of stenting below the knee (BTK), using the Xpert™ stent, for treatment of critical limb ischemia (CLI).
Why is RELAX (REvascularization of Leg Arteries with the Xpert™ stent) limited to the Xpert™ stent?
The Xpert™ stent is well designed, but not approved, for BTK use. RELAX (REvascularization of Leg Arteries with the Xpert™ stent) will be the largest data set ever collected for BTK stenting for CLI. The results will establish a benchmark for comparison with drug eluting stents in future trials.
Can I submit data from patients that I have already treated?
No. You must have confirmation from your Institutional Review Board (IRB) that the RELAX (REvascularization of Leg Arteries with the Xpert™ stent) protocol and informed consent documents have been approved.
My IRB has a fee for submitting protocols. How do I pay the fee?
Most IRB’s will waive fees for Investigator Initiated Protocols that have no corporate sponsorship or reimbursement.
Do I have to consent the patient for RELAX (REvascularization of Leg Arteries with the Xpert™ stent) prior to treatment?
No. Patients may be consented within 30 days of treatment. However, you must consent all patients that you treat (consecutive enrollment). In other words, if you use the Xpert™ stent BTK for CLI, you must consent the patient and enroll in the RELAX (REvascularization of Leg Arteries with the Xpert™ stent) registry within 30 days. There are no exclusion criteria for the registry. Data will be collected at 30 days, 6 months and one year via the secure RELAX (REvascularization of Leg Arteries with the Xpert™ stent) web site.
What if I need to treat above the knee as well as BTK to adequately revascularize the patient?
Complete revascularization is encouraged (recommended). The RELAX (REvascularization of Leg Arteries with the Xpert™ stent) registry will discriminate between target vessel revascularization (TVR) related to Xpert™ stent failure and inflow problems such as femoral-popliteal graft occlusion or SFA restenosis after intervention.
Can I combine different treatment modalities? What if I limit the Xpert™ stent to failed angioplasty or atherectomy?
Both planned stenting and provisional/bailout stenting are allowed in RELAX (REvascularization of Leg Arteries with the Xpert™ stent). The registry will document adjunctive treatments.
What if I treat more than one vessel BTK?
Multi vessel treatment is allowed. You will document the most proximal segment treated that provides “straight line flow” to the foot, with a corresponding ankle or toe pressure. If two or more “unique” territories are treated, each will be reported separately. Document the total length of each treated segment. Record ankle and toe pressures.
EXAMPLES:
1. Tibial-peroneal trunk (TPT) and peroneal arteries are treated with overlapping stents, restoring single vessel runoff, with collateral flow to the foot. Report “TPT”; document the total length of the treated segment, and record ankle and toe pressures.
2. Both the anterior tibial (AT) and the posterior tibial (PT) arteries are stented. Report each intervention separately; “AT” for one, “PT” for the other. Document the total length of each treated segment. Record ankle and toe pressures. The same patient will have two unique entries in the RELAX (REvascularization of Leg Arteries with the Xpert™ stent) registry.
3. The AT is stented, followed by stenting of the popliteal (POP) and the PT in a “T” configuration. Report each intervention separately, “AT” for one, “POP” for the other. Document the total length of each treated segment. Record ankle and toe pressures. The same patient will have two unique entries in the RELAX (REvascularization of Leg Arteries with the Xpert™ stent) registry.
I haven’t used the Xpert™ stent yet. Is that a problem?
You must have experience with the Xpert™ stent system prior to enrolling a patient in the RELAX (REvascularization of Leg Arteries with the Xpert™ stent) registry. The Xpert™ stent does not have to be used BTK or for treatment of CLI, however.
What type of follow-up and data collection is required?
RELAX (REvascularization of Leg Arteries with the Xpert™ stent) involves standard of care follow-up and data collection. ABI’s and toe pressures are recorded post-intervention and at 30 days, 6 months and one year. Stent patency and restenosis are assessed at 6 months and one year.
Do I have to repeat an angiogram at 6 months and one year?
No. You may use Duplex/Doppler, CTA or conventional angiography to assess patency of the Xpert™ stent. You will determine percent diameter stenosis within the stent.
Will the RELAX (REvascularization of Leg Arteries with the Xpert™ stent) data be available to me?
We will have a large independent database for analysis. You will be updated on enrollment toward the goal of 1000 patients. We will publish and present the findings in their entirety.
Thank You
Remember: Take Time To RELAX
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