Paclitaxel Coated Balloon for Bowel Stricture

(PATENT-B Trial)

Recruiting at 33 trial locations

Overseen By Erika Wang

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GIE Medical

Must not be taking: Anticoagulants, Antiplatelets, Steroids, others

Disqualifiers: Pregnancy, Malignancy, Inflammation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

171 Participants Needed

Trial Summary

What is the purpose of this trial?

To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.

Will I have to stop taking my current medications?

The trial requires participants to stop using chronic systemic steroids (more than 10 mg/day) for at least 4 weeks before joining. If you are on anticoagulant or antiplatelet medications, they must be managed safely according to guidelines. Other medications are not specifically mentioned in the protocol.

What data supports the effectiveness of the treatment Paclitaxel Coated Balloon for Bowel Stricture?

Paclitaxel is known to be an effective anti-cancer drug, and its local delivery has been shown to increase its concentration at the tumor site, potentially enhancing its effectiveness. Although the research does not directly address bowel strictures, the use of paclitaxel in other conditions suggests it may have beneficial effects when applied locally. ^{1 2 3 4 5}

Is the Paclitaxel Coated Balloon generally safe for humans?

Research on various paclitaxel-coated balloons, like Stellarex and IN.PACT Admiral, shows they are generally safe for treating blood vessel issues, with no significant safety concerns reported in long-term follow-ups. However, there are rare cases of allergic reactions, such as Kounis Syndrome, which is a severe allergic reaction affecting the heart. ^{6 7 8 9 10}

How is the paclitaxel-coated balloon treatment different from other treatments for bowel stricture?

The paclitaxel-coated balloon treatment is unique because it uses a balloon coated with paclitaxel, a drug that helps prevent the narrowing of blood vessels, to treat bowel strictures. This method allows for direct delivery of the drug to the affected area, potentially reducing the risk of restenosis (re-narrowing of the vessel) compared to traditional treatments. ^{6 9 10 11 12}

Eligibility Criteria

Adults over 22 with benign bowel strictures that have been dilated twice before can join. They must be able to follow the study plan and give consent. Pregnant or breastfeeding women, those with paclitaxel allergies, or people on certain medications are excluded.

Inclusion Criteria

My stricture is 5 cm long or shorter.

I am 22 years old or older.

Willing and able to provide written informed consent

Exclusion Criteria

My condition cannot be treated with standard balloon dilation due to severe issues.

I might have a tear in my digestive tract.

My condition needs immediate medical attention.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the ProTractX3 Drug-coated balloon for recurrent benign bowel strictures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and/or virtual)

Treatment Details

Interventions

• Paclitaxel Coated Balloon

Trial Overview The trial is testing GIE Medical's ProTractX3 TTS DCB against a control for treating non-cancerous bowel narrowings. It aims to see if this treatment is safe and works well in keeping the bowels open.

Participant Groups

Group I: GIE Medical ProTractX3 TTS DCB Experimental Treatment 1 Intervention

The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.

Group II: Control Active Control 1 Intervention

Standard of Care.

Paclitaxel Coated Balloon is already approved in European Union, United States for the following indications:

Approved in European Union as Paclitaxel Coated Balloon for:

• Peripheral artery disease
• Above-the-knee PAD
• Below-the-knee PAD

Approved in United States as Paclitaxel Coated Balloon for:

• Peripheral artery disease
• Above-the-knee PAD
• Critical limb ischemia

Who Is Running the Clinical Trial?

GIE Medical

Lead Sponsor

Trials

5

Recruited

400+

Findings from Research

This case report is the first to show that nab-paclitaxel can successfully treat patients who have severe hypersensitivity reactions to paclitaxel and docetaxel.

Nab-paclitaxel is demonstrated to be a safe alternative chemotherapy option for patients who cannot tolerate traditional taxane treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful treatment with nab-paclitaxel after hypersensitivity reaction to paclitaxel and docetaxel. de Leon, MC., Bolla, S., Greene, B., et al.[2021]

Paclitaxel oleate, a lipophilic prodrug of paclitaxel, was successfully formulated into nanoparticles using a hydrophobic polymer, which allows for better drug delivery in the acidic environment of tumors, potentially replacing the toxic Cremophor EL used in traditional formulations.

The study demonstrated that paclitaxel oleate in PbAE nanoparticles showed similar cytotoxicity to free paclitaxel, with IC50 values of 123 nM and 128 nM respectively, while the prodrug in a different formulation (PCL) was significantly less effective, indicating that the new formulation enhances drug efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation and characterization of polymeric pH-sensitive STEALTH® nanoparticles for tumor delivery of a lipophilic prodrug of paclitaxel. Lundberg, BB.[2015]

Paclitaxel-conjugated micelles, especially the M(FA/PTX) formulation, demonstrated superior anti-tumor activity in breast cancer models, with a significant reduction in tumor mass and increased cell apoptosis compared to standard paclitaxel and control groups.

The M(FA/PTX) micelles not only enhanced the effectiveness of paclitaxel but also improved survival rates in tumor-bearing mice, suggesting they could be a promising treatment option for human breast cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-tumor activity of folate targeted biodegradable polymer-paclitaxel conjugate micelles on EMT-6 breast cancer model. Wu, D., Zheng, Y., Hu, X., et al.[2018]

A new method for quantifying paclitaxel (PTX) levels in plasma using HPLC with UV detection has been developed, which is reliable and efficient for clinical use, allowing for therapeutic drug monitoring.

The method demonstrated a strong linearity in measuring PTX concentrations and showed good precision, making it suitable for managing the drug's narrow therapeutic range and variability in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation method for estimation paclitaxel in plasma. Gaïes, E., Jebabli, N., Ben Said, D., et al.[2021]

The controlled-release PACLIMER Microspheres containing 40% paclitaxel significantly reduced tumor growth in prostate cancer models, indicating its efficacy as a treatment.

When combined with radiation, the 10% PACLIMER Microspheres enhanced tumor response, suggesting that this formulation can act as a radiosensitizer, improving the effectiveness of radiation therapy in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-tumor effect of combination therapy with intratumoral controlled-release paclitaxel (PACLIMER microspheres) and radiation. Lapidus, RG., Dang, W., Rosen, DM., et al.[2015]

The Stellarex® drug-coated balloon (DCB) effectively delivers a low dose of paclitaxel to treat vascular lesions, utilizing a unique hybrid formulation that ensures drug integrity and release during use.

Clinical data indicate that Stellarex maintains long-term effectiveness in treating patients without any significant safety concerns, suggesting it is a reliable option for vascular interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellarex drug-coated balloon: a technology evaluation. Nerla, R., Castriota, F., Cremonesi, A., et al.[2021]

The Pantera Lux paclitaxel-coated balloon demonstrated high clinical device success (98.2%) in treating 1,064 patients with in-stent restenosis and de novo lesions, confirming its efficacy in a real-world setting.

The study reported low rates of major adverse cardiac events (MACE) at 12 months, with an overall rate of 15.1%, indicating the safety of the intervention, along with a very low incidence of stent thrombosis at 0.4%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry. Toelg, R., Merkely, B., Erglis, A., et al.[2015]

In a study involving 18 healthy swine, the In.Pact Pacific paclitaxel-coated balloon (PCB) showed higher tissue concentrations of the drug compared to other PCB technologies (Lutonix and Ranger) at all measured time points, indicating its potential for more effective treatment.

All PCB technologies effectively reduced neointimal growth compared to control balloons, but the In.Pact PCB demonstrated superior inhibition, while the lower-dose PCBs (2 μg/mm²) resulted in more mature neointima with fewer fibrin deposits, suggesting a favorable healing response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Paclitaxel Dose on Tissue Pharmacokinetics and Vascular Healing: A Comparative Drug-Coated Balloon Study in the Familial Hypercholesterolemic Swine Model of Superficial Femoral In-Stent Restenosis. Gongora, CA., Shibuya, M., Wessler, JD., et al.[2017]

A rare case of acute coronary syndrome occurred due to anaphylaxis after using a paclitaxel-coated balloon for treating a blocked superficial femoral artery, highlighting a potential safety concern with this treatment.

Drug-coated balloons, while effective in reducing restenosis in peripheral arterial disease, may carry risks of severe allergic reactions, which clinicians should be aware of when using these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kounis Syndrome after Angioplasty of the Superficial Femoral Artery with Paclitaxel-Coated Balloon. Narroway, HG., Katib, N., Gomes, ML., et al.[2020]

In a study of 238 patients, those treated with paclitaxel-coated balloon angioplasty (PCBA) had a significantly lower 5-year mortality rate (14.0%) compared to those who received standard plain balloon angioplasty (POBA) (26.2%), indicating that PCBA may be a safer option.

However, when analyzing matched pairs of patients, there was no significant difference in mortality rates between the two groups (20.8% for PCBA vs. 26.0% for POBA), suggesting that PCBA does not increase long-term mortality compared to POBA, and the dose of paclitaxel used did not correlate with mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study. Donas, KP., Sohr, A., Pitoulias, GA., et al.[2020]

The Optilume™ paclitaxel-coated balloon treatment for recurrent bulbar urethral strictures showed no serious adverse events within 90 days, indicating a strong safety profile for this intervention.

At the 12-month follow-up, 70% of patients achieved anatomic success, suggesting promising preliminary efficacy for this treatment, warranting further long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A drug-coated balloon treatment for urethral stricture disease: Interim results from the ROBUST I study. Virasoro, R., DeLong, JM., Mann, RA., et al.[2020]

In the IN.PACT SFA Trial involving 331 patients, the paclitaxel-coated drug-coated balloon (DCB) demonstrated significantly higher primary patency rates (82.2%) compared to percutaneous transluminal angioplasty (PTA) (52.4%) at 12 months, indicating better long-term effectiveness in treating superficial femoral and popliteal artery disease.

The DCB also had a much lower rate of clinically driven target lesion revascularization (2.4% vs. 20.6% for PTA), while both treatments showed low rates of vessel thrombosis and no major complications, highlighting the DCB's favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Tepe, G., Laird, J., Schneider, P., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Successful treatment with nab-paclitaxel after hypersensitivity reaction to paclitaxel and docetaxel. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Preparation and characterization of polymeric pH-sensitive STEALTH® nanoparticles for tumor delivery of a lipophilic prodrug of paclitaxel. [2015]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Anti-tumor activity of folate targeted biodegradable polymer-paclitaxel conjugate micelles on EMT-6 breast cancer model. [2018]

4. Tunisia pubmed.ncbi.nlm.nih.gov

Development and validation method for estimation paclitaxel in plasma. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Anti-tumor effect of combination therapy with intratumoral controlled-release paclitaxel (PACLIMER microspheres) and radiation. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Stellarex drug-coated balloon: a technology evaluation. [2021]

7. France pubmed.ncbi.nlm.nih.gov

Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of Paclitaxel Dose on Tissue Pharmacokinetics and Vascular Healing: A Comparative Drug-Coated Balloon Study in the Familial Hypercholesterolemic Swine Model of Superficial Femoral In-Stent Restenosis. [2017]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Kounis Syndrome after Angioplasty of the Superficial Femoral Artery with Paclitaxel-Coated Balloon. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study. [2020]

11. Canada pubmed.ncbi.nlm.nih.gov

A drug-coated balloon treatment for urethral stricture disease: Interim results from the ROBUST I study. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. [2022]